Acoustic Reflection Method and Work of Breathing (MAVAS)

This study has been terminated.
(No inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00950443
First received: July 30, 2009
Last updated: December 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Airway Obstruction
Device: Acoustic reflection method
Device: Acoustic method and breathing/endoscopic evaluation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • To compare the importance and the localisation of the UAO assessed by the acoustic reflection method and by the endoscopic evaluation under general anaesthesia [ Time Frame: At the inclusion visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the feasibility of the acoustic method for the evaluation of UAO in children [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • To compare the importance of the UAO assessed by the acoustic reflection method with the measurements of the work of breathing [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • To correlate the importance and the localisation of the UAO assessed by the acoustic reflection method with the outcome of surgery if required [ Time Frame: At the inclusion and 3 months visits ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Children with upper airway obstruction
Device: Acoustic method and breathing/endoscopic evaluation
Endoscopic evaluation done under general anaesthesia.
Other Name: Acoustic method and breathing/endoscopic evaluation
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950443

Locations
France
Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nicolas LEBOULANGER, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00950443     History of Changes
Other Study ID Numbers: P 080606
Study First Received: July 30, 2009
Last Updated: December 26, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Upper airway obstruction
child
acoustic reflection method
endoscopy
work of breathing
sleep study
CT scan

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014