Clinical trial NCT00950443: Acoustic Reflection Method and Work of Breathing
Official title: Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Airway Obstruction
Keywords: Upper airway obstruction
child
acoustic reflection method
endoscopy
work of breathing
sleep study
CT scan
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 38
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: To compare the importance and the localisation of the UAO assessed by the acoustic reflection method and by the endoscopic evaluation under general anaesthesia
timeFrame: At the inclusion visit
Secondary outcomes:
measure: To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
timeFrame: At the inclusion visit
measure: 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
timeFrame: At the inclusion visit
measure: To compare the importance of the UAO assessed by the acoustic reflection method with the measurements of the work of breathing
timeFrame: At the inclusion visit
measure: 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
timeFrame: At the inclusion visit
measure: To correlate the importance and the localisation of the UAO assessed by the acoustic reflection method with the outcome of surgery if required
timeFrame: At the inclusion and 3 months visits
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas LEBOULANGER, MD
role: PRINCIPAL_INVESTIGATOR
References: