Clinical Trials Logo

Clinical Trial Summary

Upper airway obstruction (UAO) is very common in children. Presently, the importance of the UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.

The aim of the study is to evaluate two new techniques to quantify the importance of the UAO in children; the acoustic reflection method and the measurement of the work of breathing.

80 children will be included in this monocentric, prospective, open labelled study.


Clinical Trial Description

The following evaluations will be performed the day prior to the endoscopic evaluation :1) calculation of a clinical score based on the diurnal and nocturnal respiratory and nutritional tolerance of the UAO, 2) evaluation of the importance and the localisation of the UAO assessed by the acoustic reflection method, 3) measurement of the work of breathing, 4) recording of nocturnal gas exchange during at least 6 hours by s single monitor (Sentec™) which measures pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2), and evaluation of sleep quality by actigraphy (recording of patient's movements by an Actiwatch™).

All the patients will be re-assessed after 3 months. If no treatment is required, a second clinical evaluation with an acoustic reflection examination will be performed. If a surgical treatment or a noninvasive positive pressure ventilation will be necessary, a second complete evaluation will be performed with an endoscopic examination, the calculation of the clinical score, an acoustic reflection examination, the measurement of the work of breathing, and the recording of the nocturnal gas exchange and sleep quality. This second endoscopic examination will be performed only for medical purpose and not for research only.

The study will last 24 months, comprising 21 months for the inclusion of the patients and 3 months for the analysis of the data. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00950443
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Terminated
Phase N/A
Start date December 2009
Completion date November 2011

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04506346 - Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Completed NCT02106143 - RejuvenAir™ System Lobectomy Safety and Histology Study N/A
Completed NCT03274791 - Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD N/A
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT03656315 - Scoring System to Predict Depth of Cricothyroid Membrane N/A
Recruiting NCT05880836 - In Line Aerosol Nebulization With High Flow N/A
Recruiting NCT05573919 - VivAer: A Correlation Between Symptom Scores and Objective Findings N/A
Completed NCT02403934 - Jaw Elevation Device in Deep Sedation Study N/A
Recruiting NCT00452062 - Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults Phase 2
Completed NCT02563210 - Airway Resistance Measurement in Children 3 to 6 Years of Age N/A
Completed NCT03488849 - SureCRIC Standardized Patient Study
Completed NCT03752593 - The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Recruiting NCT05974488 - The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE N/A
Not yet recruiting NCT02975791 - Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane N/A
Completed NCT00788788 - Heliox in Experimental Upper Airway Obstruction Phase 1/Phase 2
Not yet recruiting NCT06128811 - Dental Isolation Systems Among Pediatric Patients With Different Airway Patency N/A
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Completed NCT03165461 - Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Recruiting NCT03969147 - Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway N/A