Acoustic Reflection Method and Work of Breathing

NCT00950443 | Terminated

• 1 other identifier: P 080606
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Airway Obstruction

Keywords

Upper airway obstruction; child; acoustic reflection method; endoscopy; work of breathing; sleep study; CT scan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

Children with upper airway obstruction

Device: Acoustic method and breathing/endoscopic evaluation

2

ACTIVE COMPARATOR

Children without upper airway obstruction

Device: Acoustic reflection method

Interventions

Acoustic reflection method DEVICE

Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.

2

Acoustic method and breathing/endoscopic evaluation DEVICE

Endoscopic evaluation done under general anaesthesia.

1

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• UAO due solely to a hypertrophy of the adenoids and/or the tonsils,
• patients with a tracheostomy or a non operated cleft palate

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department

Paris, 75020, France

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Nicolas LEBOULANGER, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 29, 2011

Record last verified: 2011-08

Locations

FR (1)