Airway ObstructionMAVASNCT00950443
Acoustic Reflection Method and Work of Breathing
A study testing Acoustic reflection method and Acoustic method and breathing/endoscopic evaluation in people with Airway Obstruction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- Acoustic reflection method and Acoustic method and breathing/endoscopic evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- UAO due solely to a hypertrophy of the adenoids and/or the tonsils,
- patients with a tracheostomy or a non operated cleft palate
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Armand Trousseau, Pediatric Pulmonology department and ENT department
Paris, 75020
About this study
Official title: Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction
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.
Read the 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.
- Conditions
- Airway Obstruction
- Being tested
- Acoustic reflection method, Acoustic method and breathing/endoscopic evaluation
- Keywords
- Upper airway obstruction, child, acoustic reflection method, endoscopy, work of breathing, sleep study, CT scan
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic reflection methodDevice
Acoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway.
Acoustic method and breathing/endoscopic evaluationDevice
Endoscopic evaluation done under general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children with upper airway obstruction Receives: Device: Acoustic method and breathing/endoscopic evaluation |
| 2 | Active comparator | Children without upper airway obstruction Receives: Device: Acoustic reflection method |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the importance and the localisation of the UAO assessed by the acoustic reflection method and by the endoscopic evaluation under general anaesthesia
Measured: At the inclusion visit
Secondary outcomes (5)
To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the inclusion and 3 months visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionNov 2011
Why it stopped: No inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas LEBOULANGER, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950443
- Sponsor's protocol ID
- P 080606
- Acronym
- MAVAS
- Status last verified
- Aug 2011
- First submitted
- 30 Jul 2009
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Reflection Method and Work of Breathing : Two New Methods to Measure Children's Upper Airway Obstruction
- ClinicalTrials.gov ID
- NCT00950443
- Acronym / sponsor ID
- MAVAS / P 080606
- Conditions
- Airway Obstruction
- Keywords
- Upper airway obstruction, child, acoustic reflection method, endoscopy, work of breathing, sleep study, CT scan
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No inclusion
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Acoustic method and breathing/endoscopic evaluationChildren with upper airway obstruction |
| 2 | Active comparator | Device: Acoustic reflection methodChildren without upper airway obstruction |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- UAO due solely to a hypertrophy of the adenoids and/or the tonsils,
- patients with a tracheostomy or a non operated cleft palate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic reflection methodAcoustic reflection gives the longitudinal cross-sectional area profile along airway.Based on planar acoustic wave propagating in a rigid duct connected to airway. | Device | 2 |
| Acoustic method and breathing/endoscopic evaluationEndoscopic evaluation done under general anaesthesia. | Device | 1 |
Primary outcome
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
5 secondary outcomes
To evaluate the feasibility of the acoustic method for the evaluation of UAO in children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the inclusion and 3 months visits
Results and safety
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas LEBOULANGER, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic reflection method and Acoustic method and breathing/endoscopic evaluation in people with Airway Obstruction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At the inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.