Acoustic Reflection Method and Work of Breathing

Airway Obstruction Clinical Trial

— MAVAS  

Official title:

Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00950443
• Other study ID #: P 080606
• Status: Terminated
• Phase: N/A
• First received: July 30, 2009
• Last updated: December 26, 2011
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

• children aged 0 to 15 years old,

• in a stable state,

• presenting an UAO which requires an endoscopic evaluation under general anaesthesia

• signed informed consent

• affiliation to french health benefits

Exclusion Criteria:

• UAO due solely to a hypertrophy of the adenoids and/or the tonsils,

• patients with a tracheostomy or a non operated cleft palate

Study Design

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

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• Acoustic reflection method
Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.
• Acoustic method and breathing/endoscopic evaluation
Endoscopic evaluation done under general anaesthesia.

Locations

Country	Name	City	State
France	Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the importance and the localisation of the UAO assessed by the acoustic reflection method and by the endoscopic evaluation under general anaesthesia		At the inclusion visit	Yes
Secondary	To evaluate the feasibility of the acoustic method for the evaluation of UAO in children		At the inclusion visit	No
Secondary	To compare the importance and the localisation of the UAO assessed by the acoustic reflection method with the respiratory (during sleep and wakefulness) and nutritional consequences of the UAO		At the inclusion visit	No
Secondary	To compare the importance of the UAO assessed by the acoustic reflection method with the measurements of the work of breathing		At the inclusion visit	No
Secondary	To compare the importance and the localisation of the UAO assessed by the acoustic reflection method with the results of a high resolution computed tomography scan of the upper airways if done for the medical reasons		At the inclusion visit	No
Secondary	To correlate the importance and the localisation of the UAO assessed by the acoustic reflection method with the outcome of surgery if required		At the inclusion and 3 months visits	No