Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Tracheal Disorders from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 23
- Active, not recruiting: 2
- Completed: 14
- Other: 11
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT02530073 — Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Connecticut Children’s Medical Center |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernias |
| Interventions |
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
NCT03556228 — VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Sponsor | VM Oncology, LLC |
| Enrollment | 242 |
| Study Type | INTERVENTIONAL |
| Conditions | Head and Neck Carcinoma; Adenoid Cystic Carcinoma; Lung Cancer; Non-Small Cell Lung Cancer; Pancreatic Cancer |
| Interventions | ; |
This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
NCT03980717 — Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Michael A Belfort |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth h…
NCT04583644 — Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Hanmin Lee |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Pre…
NCT05284006 — Non-invasive Functional Assessment and Pathogenesis of Morquio A
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Nemours Children’s Clinic |
| Enrollment | 60 |
| Study Type | OBSERVATIONAL |
| Conditions | Mucopolysaccharidosis IV Type A; Morquio A Syndrome; MPS IVA |
| Interventions |
Morquio A disease is a devastating systemic skeletal disease in which detailed progression and pathogenesis remain unknown. The proposed project aims to establish a non-invasive objective assessment that can be applicable to all ages of patients to better understand the progress of their disease and the most serious clinical problems (cervical instability and stenosis, tracheal obstruction, hyp…
NCT05450653 — Trial of FETO for Severe Congenital Diaphragmatic Hernia
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Aimen F. Shaaban, MD |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann & Robert H. Lurie Children’s Hospital of Chicago (Lurie Children’s). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10…
NCT04217603 — Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Beth Israel Deaconess Medical Center |
| Enrollment | 32 |
| Study Type | INTERVENTIONAL |
| Conditions | Tracheobronchomalacia; Excessive Dynamic Airway Collapse |
| Interventions | ; |
The purpose of this protocol is to perform a prospective, randomized, double-blinded, pacebo-controlled clinical trial to determine the influence of a non-invasive positive pressure ventilation device on exercise capacity and symptoms in adult patients with ECAC. Primary outcome will include the total distance traversed by the study subject during a standard 6-minute walk test, and secondary ou…
NCT05461222 — Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Yair Blumenfeld |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and be…
NCT06085209 — Cryospray Therapy for Benign Airway Stenosis
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Virginia Commonwealth University |
| Enrollment | 12 |
| Study Type | INTERVENTIONAL |
| Conditions | Stenosis Trachea |
| Interventions | ; ; |
This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at…
NCT05421676 — Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of California, Davis |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational ag…
NCT03138863 — Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Rodrigo Ruano |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary Artery Hypertension |
| Interventions | ; |
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
NCT06638931 — Agnostic Therapy in Rare Solid Tumors
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Enrollment | 28 |
| Study Type | INTERVENTIONAL |
| Conditions | Urachal Cancer; Parathyroid Carcinoma; Fibrolamellar Carcinoma; Angiosarcoma; Secretory Carcinoma of Breast |
| Interventions |
The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.
The study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor’s tissue type or location. Patients who have not responded to standard treatments will be included, …
NCT07687628 — Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Papa Giovanni XXIII Hospital |
| Enrollment | 60 |
| Study Type | OBSERVATIONAL |
| Conditions | Tracheoesophageal Fistula; Esophageal Atresia With Tracheo-esophageal Fistula |
| Interventions | ; |
The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.
NCT06406452 — Bioresorbable Airway Splint Pivotal Clinical Trial
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of Michigan |
| Enrollment | 35 |
| Study Type | INTERVENTIONAL |
| Conditions | Tracheobronchomalacia |
| Interventions |
The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children.
The airway splint is bioresorbable, meaning the child’s body will absorb the splint over about five years.
NCT06893458 — Feeding Difficulties and Quality of Life in Children With Tracheal Cannula
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Karolinska Institutet |
| Enrollment | 80 |
| Study Type | OBSERVATIONAL |
| Conditions | Quality of Life (QOL); Tracheostomy; Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter; Feeding Difficulties; Swallowing Difficulties |
The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula.
The main questions it aims to answer are
- What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children?
- How do child…
NCT06967896 — Different Models of Tracheal Catheters Are Used for Female Thyroid Glands
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Anqing Municipal Hospital |
| Enrollment | 180 |
| Study Type | OBSERVATIONAL |
| Conditions | Sore Throat; Tracheal Tubes With an Inner Diameter of 6.0mm; Tracheal Tubes With an Inner Diameter of 6.5mm; Tracheal Tubes With an Inner Diameter of 7.0mm |
Objective:Compare whether the use of tracheal catheters of models 6.0 and 6.5 causes less sore throat in women after thyroid surgery compared with the traditional use of model 7.0 tracheal catheters.Methods: Investigators enrolled 180 female patients with American Society of Anesthesiologists (ASA) physical status I and III, aged 18-65 years, and scheduled for elective undergoing thyroid surger…
NCT07166172 — Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Johns Hopkins University |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia; Congenital Abnormalities; Neonatal Diseases and Abnormalities; Hernia, DIaphragmatic, Congenital; Internal Hernia |
| Interventions |
This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR < 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the chil…
NCT06935110 — Feasibility of Tracheobronchial Defect Reconstruction Using Allogenic Aortic Patch
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Taiwan University Hospital |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Trachea Diseases; Airway Remodeling; Reconstruction Surgery |
| Interventions |
The investigators investigate the feasibility and safety of using cryopreserved aortic patches for tracheal or bronchial defect repair.
NCT07191860 — Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Airiver Medical, Inc. |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Adult Subjects With Symptomatic Benign Airway Obstruction; Adult Benign Central Airway Stenosis; Adult Tracheobronchial Stenosis; Tracheal Stenosis; Central Airway Stenosis |
| Interventions | ; |
The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon dilation, respectively.
NCT07559591 — High Flow Tracheal Oxygen for Weaning of Tracheostomized Patients
| Status | Recruiting |
| Phase | N/A |
| Sponsor | King Faisal Specialist Hospital & Research Center |
| Enrollment | 88 |
| Study Type | INTERVENTIONAL |
| Conditions | Tracheostomized Patients; Mechanical Ventilation Weaning; High Flow Oxygen Therapy |
| Interventions | ; |
In this pilot randomized controlled trial (RCT), the investigators aim to explore the feasibility of conducting a powered RCT that examines the efficacy and safety of high flow tracheal oxygen (HFTO) in weaning critically ill tracheostomy patients from mechanical ventilation.
Objective of the study
- To assess the feasibility of conducting a larger RCT as primary objective.
- To explore the…
NCT05354505 — Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Vincent Duron |
| Enrollment | 10 |
| Study Type | INTERVENTIONAL |
| Conditions | Diaphragmatic Hernia |
| Interventions |
This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).
NCT07577414 — Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Dr Erin Perrone |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
NCT05962346 — Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Mauro H. Schenone |
| Enrollment | 20 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions | ; ; |
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
Active, Not Recruiting
NCT02834013 — Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 798 |
| Study Type | INTERVENTIONAL |
| Conditions | Acinar Cell Carcinoma; Adenoid Cystic Carcinoma; Adrenal Cortical Carcinoma; Adrenal Gland Pheochromocytoma; Anal Canal Neuroendocrine Carcinoma |
| Interventions | ; ; |
This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
This trial enrolls participants for the following cohorts based on condition:
- Epithelial tumors of na…
NCT06179472 — Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Inna Lobeck |
| Enrollment | 20 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children’s Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right co…
Not Yet Recruiting
NCT06848010 — TRacheal Cuff PRessure Evaluation Study
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Policlinico Hospital |
| Enrollment | 54 |
| Study Type | INTERVENTIONAL |
| Conditions | Pneumonia, Ventilator-Associated; Mechanical Ventilation |
| Interventions |
Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).
Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will …
NCT07463742 — Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | University of Maryland, Baltimore |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Tracheal Stenosis |
| Interventions | ; |
Some people develop a narrowing of their windpipe (trachea), called benign tracheal stenosis, which can make it hard to breathe. Doctors often treat this by using a bronchoscope-a thin, flexible tube with a camera-to open up the airway or remove scar tissue. While these procedures help patients breathe better, we do not fully understand why the narrowing occurs or how the tissue heals afterward…
NCT07587736 — The Role of Ultrasonographic Tracheal Measurements in Predicting Hypoxemia During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Ankara Ataturk Sanatorium Training and Research Hospital |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION; Hypoxemia; Trachea |
| Interventions | ; |
Bronchoscopic procedures performed under endobronchial ultrasound (EBUS) guidance are widely used minimally invasive diagnostic methods for the evaluation of mediastinal lymph nodes. Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) is an indicated procedure for the diagnosis, staging, and histopathological characterization of primary or metastatic tumors. The procedu…
NCT07609147 — Ultrasound Measurement of Skin-to-Epiglottis Distance for Prediction of Difficult Airway in Adult Patients
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Hacettepe University |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Airway Assessment; Tracheal Intubation, Elective Surgery; Tracheal Diamater Measurement; Ultrasound Evaluation of Airway |
This prospective observational study aims to evaluate the predictive value of ultrasound-measured skin-to-epiglottis distance for difficult airway in adult patients undergoing elective or emergency procedures requiring airway management. The correlation between ultrasound measurements and standard airway assessment parameters will be analyzed.
NCT07564297 — North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Mayo Clinic |
| Enrollment | 80 |
| Study Type | OBSERVATIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions | ; |
The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy
NCT07574450 — Taiwan ED Airway Quality Surveillance Registry (TEAR)
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Chang Gung Memorial Hospital |
| Enrollment | 1200 |
| Study Type | OBSERVATIONAL |
| Conditions | Airway Management; Tracheal Intubation; Emergency Department; Peri-intubation Adverse Events |
This prospective, multicenter observational registry systematically captures all emergency department tracheal intubations across participating hospitals in Taiwan. The registry focuses on process quality indicators, including first-pass success, and patient-safety outcomes, including hypoxemia, hypotension, and peri-intubation cardiac arrest within 30 minutes of intubation. Routinely generated…
NCT07650552 — Fentanyl and Rocuronium for Tracheal Intubation in Newborns
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Sponsor | UEA - Universidade Do Estado Do Amazonas |
| Enrollment | 102 |
| Study Type | INTERVENTIONAL |
| Conditions | Infant, Premature; Intubation, Intratracheal; Respiratory Distress Syndrome, Newborn; Apnea of Prematurity |
| Interventions | ; |
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and …
Enrolling by Invitation
NCT07223762 — Hyperangulated Versus Standard Geometry Laryngoscope Blade Trial
| Status | Enrolling by invitation |
| Phase | N/A |
| Sponsor | Vanderbilt University Medical Center |
| Enrollment | 2500 |
| Study Type | INTERVENTIONAL |
| Conditions | Acute Respiratory Failure |
| Interventions | ; |
The Hyperangulated versus Standard Geometry Laryngoscope Blade (ANGLE) Trial is a multi-center, non-blinded, parallel-group, randomized clinical trial evaluating the effect of use of a hyperangulated video laryngoscope blade versus use of a standard geometry video laryngoscope blade. Critically ill adults undergoing tracheal intubation in participating EDs and ICUs who meet eligibility criteria…
NCT07217197 — Respiratory Monitoring System That Detects & Predicts OIRD
| Status | Enrolling by invitation |
| Phase | N/A |
| Sponsor | Thomas Jefferson University |
| Enrollment | 120 |
| Study Type | INTERVENTIONAL |
| Conditions | Respiration Disorders |
| Interventions |
This study is being conducted to evaluate the ability of the Respiratory Monitoring System (RMS) to detect and predict opioid induced respiratory depression (OIRD) in post-operative surgical patients managed with opioid medications. The ability of the RMS to detect OIRD will be compared to the detection of OIRD using a commercial capnometer, pulse oximeter, airflow monitor, and breathing volume…
Completed Trials
NCT01082666 — Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | University Hospital, Lille |
| Enrollment | 122 |
| Study Type | INTERVENTIONAL |
| Conditions | Critically Ill |
| Interventions | ; |
We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
NCT01965821 — Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Lille |
| Enrollment | 18 |
| Study Type | INTERVENTIONAL |
| Conditions | Critical Illness |
| Interventions | ; |
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions. The aim of this study is to determine the efficiency of Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintec…
NCT01948635 — Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Lille |
| Enrollment | 326 |
| Study Type | INTERVENTIONAL |
| Conditions | Critical Illness; Mechanical Ventilation Complication; Ventilator Associated Pneumonia |
| Interventions | ; |
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
NCT03681626 — Does Tracheal Suction During Extubation in Intensive Care Unit Decrease Functional Residual Capacity
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Rouen |
| Enrollment | 60 |
| Study Type | OBSERVATIONAL |
| Conditions | Critically Ill; Extubation; Intensive Care Unit |
| Interventions | ; |
Little is known about the procedure of extubation of patients admitted in Intensive Care Units (ICU). In particular, effects of tracheal suction during extubation have never been evaluated. Tracheal suction induces alveolar derecruitment in sedated patients under mechanical ventilation and is a major source of pain.
The aim of this study was to evaluate the impact of tracheal suction during th…
NCT02632344 — Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Enrollment | 21 |
| Study Type | INTERVENTIONAL |
| Conditions | Recurrent Respiratory Papillomatosis |
| Interventions |
This research study is evaluating an immune modulatory agent as a possible treatment for patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the treating agent.
NCT03763799 — Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d’ Inhalation
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Lille |
| Enrollment | 266 |
| Study Type | INTERVENTIONAL |
| Conditions | Aspiration Pneumonia |
| Interventions | ; |
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initi…
NCT04052828 — Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
| Status | Completed |
| Phase | N/A |
| Sponsor | Dr Erin Perrone |
| Enrollment | 4 |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 2…
NCT04879290 — Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Caen |
| Enrollment | 119 |
| Study Type | INTERVENTIONAL |
| Conditions | Anesthesia; Atelectasis; Postoperative Complications; Hypoxemia; Hyperoxia |
| Interventions | ; |
The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.
NCT05277896 — Randomized Trial of Sedative Choice for Intubation
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Enrollment | 2367 |
| Study Type | INTERVENTIONAL |
| Conditions | Acute Respiratory Failure |
| Interventions | ; |
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketami…
NCT04381949 — Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Rouen |
| Enrollment | 208 |
| Study Type | INTERVENTIONAL |
| Conditions | Airway Management; Tracheal Extubation; Postoperative Respiratory Complications; Postoperative Hypoxemia; Atelectasis |
| Interventions |
Evaluation of a postoperative tracheal extubation protocol under positive pressure in accordance with international recommendations.
Two arms: the first with “classic” extubation with disconnection of the respirator and the second with extubation without disconnection of the respiratory, as recommended.
Computer Randomization with a 1: 1 ration
NCT05153668 — Everolimus Trial in Laryngotracheal Stenosis
| Status | Completed |
| Phase | Early Phase 1 |
| Sponsor | Johns Hopkins University |
| Enrollment | 8 |
| Study Type | INTERVENTIONAL |
| Conditions | Idiopathic Subglottic Tracheal Stenosis |
| Interventions |
Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. The proposed Adjuvant EveRolimus Outcomes (AERO) trial is proof-of-concept study using the immunosuppressant drug, ev…
NCT05542823 — Effect of Cuff Pressure of Endotracheal Tube on POST
| Status | Completed |
| Phase | N/A |
| Sponsor | Seoul National University Hospital |
| Enrollment | 337 |
| Study Type | OBSERVATIONAL |
| Conditions | Laparoscopic Surgery; Tracheal Intubation Morbidity; Sore-throat |
The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.
NCT06218836 — Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat
| Status | Completed |
| Phase | N/A |
| Sponsor | Sir Ganga Ram Hospital |
| Enrollment | 250 |
| Study Type | INTERVENTIONAL |
| Conditions | Postoperative Sore Throat |
| Interventions | ; |
Postoperative sore throat (POST) is a common morbidity following upper airway access-control with direct laryngoscopy-intubation (DLI) technique. Various reasons (size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others) have been cited and management strategies (pharmacologic: applying lidocaine gel/EMLA cream on the cuff surface; non-pharmacologic measures: trac…
NCT06689748 — Curriculum for Airway Skills in Critically Ill Adults: a Delphi Evaluation
| Status | Completed |
| Phase | N/A |
| Sponsor | University of Texas Southwestern Medical Center |
| Enrollment | 50 |
| Study Type | OBSERVATIONAL |
| Conditions | Airway Management; Tracheal Intubation; Critical Illness; Training |
| Interventions |
This study using a Delphi methodology, and involving international experts, will help define a training curriculum for physicians involved with airway management in critically ill patients.
Other (Terminated)
NCT04719845 — DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis
| Status | Terminated |
| Phase | N/A |
| Sponsor | Centre de Recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
| Enrollment | 108 |
| Study Type | INTERVENTIONAL |
| Conditions | Tracheal Stenosis |
| Interventions | ; |
Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.
Other (Withdrawn)
NCT06281717 — Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
| Status | Withdrawn |
| Phase | N/A |
| Sponsor | Eyal Krispin |
| Enrollment | N/A |
| Study Type | INTERVENTIONAL |
| Conditions | Congenital Diaphragmatic Hernia |
| Interventions |
The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.
This study will enroll 10 pregna…