Acoustic Reflection Method and Work of Breathing (MAVAS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: Acoustic method and breathing/endoscopic evaluation; Device: Acoustic reflection method

Detailed 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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Children with upper airway obstruction	Device: Acoustic method and breathing/endoscopic evaluation; Endoscopic evaluation done under general anaesthesia.
Active Comparator: 2; Children without upper airway obstruction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the feasibility of the acoustic method for the evaluation of UAO in children	At the inclusion visit
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nicolas LEBOULANGER, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Estimate): December 29, 2011
• Last Update Submitted That Met QC Criteria: December 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: endoscopy; child; work of breathing; CT scan; Upper airway obstruction; sleep study; acoustic reflection method
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: P 080606