Acoustic Reflection Method and Work of Breathing (MAVAS)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Airway Obstruction

Treatments: Device: Acoustic reflection method; Device: Acoustic method and breathing/endoscopic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT00950443

P 080606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

Children with upper airway obstruction

Treatment:

Device: Acoustic method and breathing/endoscopic evaluation

2

Active Comparator group

Description:

Children without upper airway obstruction

Treatment:

Device: Acoustic reflection method