Clinical Trials Logo

Clinical Trial Summary

The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided into trachea in the stenotic area, through the wide canal of supraglottic device i-Gel. Every dilatation cession consists of three consequent tracheal balloon dilatations of maximum 3 minutes duration each, followed by 10-15minutes interval of controlled ventilation. The balloon is inflated for 60 seconds to reach predefined pressure, and then deflated. This method is minimal traumatic for tracheal mucosa, and application of several dilatation procedures every 2-3months, in pediatric patients with acquired tracheal stenosis, may lead to a relative reopening of trachea and recession of clinical symptoms.For the right performance of the dilatation procedure, patients receive general anesthesia with cessation of spontaneous ventilation. During procedure, controlled ventilation-oxygenation is impossible, because the i-Gel canal is occupied by bronchoscope and balloon catheter, so patients will remain apneic for a short period of time. For pediatric patients is important to perform proper preoxygenation prior to procedure, and to maintain oxygenation as long as possible during procedure. This is achieved by application of apneic oxygenation, through a small catheter, connected to high flow oxygen. Participants are exposed during first dilation to no oxygenation, while during second and third dilatation to apneic oxygenation. Aim of the study is to investigate primarily whether application of apneic oxygenation, in pediatric patients during tracheal balloon dilatation, maintains regional cerebral oxygen saturation rSO2 in significant higher levels, compared with no application of oxygenation. rSO2 levels are a sensitive index of oxygenation efficacy of the brain, accordingly this refers to a safe procedure. Secondary issues are whether application of apneic oxygenation maintains pulse oximetry SpO2 and artierial oxygen partial pressure PaO2 in higher levels, and what are the effects on arterial carbon dioxide partial pressure PaCO2 and on haemodynamic parameters (heart rate, blood pressure), compared with no application of apneic oxygenation.

Clinical Trial Description

The study is taking place in the Bronchoscopy Unit of the 3rd Pediatric Dpt of the Aristotles University of Thessaloniki, in the area of the Operating Rooms in the Hippokratic General Hospital of Thessaloniki, Greece. The procedure of tracheal balloon dilatation was developed and performed in Hippokratic General Hospital of Thessaloniki, Greece, for the last three years. From October 2020, pediatric patients are recruited and enrolled in this study, according to specific criteria, set by the Collaborators of the Pulmonology and Bronchoscopy Unit of the 3rd Pediatric Dpt of Aristotles University of Thessaloniki, Greece. Prior to the dilatation procedure, following steps are necessary, performed by the Principal Investigator: 1.detailed preanesthetic evaluation of the participant, for recognition of clinical signs or pathology, that can complicate the procedure and jeopardize health status 2. written informed consents from parents/caregivers, for anesthesia procedure, for tracheal dilatation procedure, and for participation in the study. All recordings during procedures are performed by the Principal Investigator, and double checked by two Collaborators.In cases of appearance of adverse events during the procedure (i.e. severe desaturation, anaphylactic reaction, severe bronchospasm), it is automatically discontinued, advanced life support is initiated, anesthesia is terminated, and participants are closely monitored during recovery. Sample size calculation was performed according to G* power analysis and the Means test: for extraction of results is necessary to record at least five different pediatric patients, who will undergo at least four tracheal dilatation cessions. For statistical analysis, quantitative variables will be described as median values and standard deviation (or IQR), qualitative variables as frequencies and percentages, while significancy level will be defined as <0.05. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05028023
Study type Interventional
Source Aristotle University Of Thessaloniki
Contact Despoina Iordanidou, MD, MSc
Phone 00306944223403
Email [email protected]
Status Recruiting
Phase N/A
Start date October 21, 2020
Completion date August 31, 2022

See also
  Status Clinical Trial Phase
Suspended NCT02949414 - A Study to Assess the Safety, Tolerability and Potential Efficacy of a Tracheal Replacement Consisting of a Tissue-engineered Tracheal Scaffold With Seeded Mesenchymal Cells Phase 1
Not yet recruiting NCT03411928 - Endotracheal Dilator to Improve Oxygenation N/A
Completed NCT02796326 - Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures N/A
Recruiting NCT02961387 - A Clinical Trial on Effectiveness and Safety of Hydrogen Generator to Treat Dyspnea for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study N/A
Completed NCT02855502 - Investigation of the Effect of Systemic Steroids on Treatment and Prevention of Recurrent Tracheal Stenosis in Postoperative Patients Phase 4
Completed NCT04674995 - Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
Completed NCT01331863 - Airway and/or Pulmonary Vessels Transplantation Phase 1/Phase 2
Active, not recruiting NCT02620319 - Biodegradable Stents in the Management of Stenoses of the Large Airways N/A
Recruiting NCT03455881 - Phenotypic and Genetic Assessment of Tracheal and Esophageal Birth Defects in Patients
Completed NCT00705848 - Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis N/A
Completed NCT03130374 - Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells Phase 1/Phase 2
Not yet recruiting NCT04625400 - Role of Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis N/A
Enrolling by invitation NCT04850742 - Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices N/A
Recruiting NCT04719845 - DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis N/A
Recruiting NCT04686721 - Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients
Terminated NCT01523275 - Study of Mitomycin-C Application in Laryngotracheal Stenosis N/A
Withdrawn NCT01977911 - Clinical Trial of Stem Cell Based Tissue Engineered Laryngeal Implants Phase 1/Phase 2
Withdrawn NCT00583960 - Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea N/A