Acoustic Reflection Method and Work of Breathing (MAVAS)
Primary Purpose
Airway Obstruction
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acoustic reflection method
Acoustic method and breathing/endoscopic evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Airway Obstruction focused on measuring Upper airway obstruction, child, acoustic reflection method, endoscopy, work of breathing, sleep study, CT scan
Eligibility 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
Sites / Locations
- Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Children with upper airway obstruction
Children without upper airway obstruction
Outcomes
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
Secondary Outcome Measures
To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
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
To compare the importance of the UAO assessed by the acoustic reflection method with the measurements of the work of breathing
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
To correlate the importance and the localisation of the UAO assessed by the acoustic reflection method with the outcome of surgery if required
Full Information
NCT ID
NCT00950443
First Posted
July 30, 2009
Last Updated
December 26, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00950443
Brief Title
Acoustic Reflection Method and Work of Breathing
Acronym
MAVAS
Official Title
Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
No inclusion
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction
Keywords
Upper airway obstruction, child, acoustic reflection method, endoscopy, work of breathing, sleep study, CT scan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Children with upper airway obstruction
Arm Title
2
Arm Type
Active Comparator
Arm Description
Children without upper airway obstruction
Intervention Type
Device
Intervention Name(s)
Acoustic reflection method
Intervention Description
Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.
Intervention Type
Device
Intervention Name(s)
Acoustic method and breathing/endoscopic evaluation
Intervention Description
Endoscopic evaluation done under general anaesthesia.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Time Frame
At the inclusion visit
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas LEBOULANGER, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
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Acoustic Reflection Method and Work of Breathing
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