AtelectasisNCT03112811
Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
A study testing Autogenic drainage and Intrapulmonary percussive ventilation in people with Atelectasis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Autogenic drainage and Intrapulmonary percussive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Apr 2007to 1 Jan 2021
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child < 10 kg
- Hospitalization in the pediatric intensive care
- Presence of an atelectasis to the radiography and/or to the lung ultrasound
- Presence of an invasive ventilation or a non-invasive ventilation
- Criteria of cardio-respiratory stability met
Who cannot join
- Absence of the physiotherapist and the radiologist referents (by ex: at night)
- Prematurity
- Neuromuscular disease
- Ventilation by high-frequency oscillation
- Extraphysical Assistance
- Patient cardiac post-surgery with closure postponed from the thorax. In the closure of the thorax, the patient becomes eligible
- Intracranial pressure > 20 mmHg or clinical signs of intracranial high blood pressure
Trial locations and contacts
1 site in 1 country.
Damien Moerman, PT contact
Belgium1 site, 1 recruiting
- Recruiting
Study site
Brussels
Damien M Moerman, PT, damien.moerman@uclouvain.be
About this study
Official title: Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care
The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.
- Conditions
- Atelectasis
- Being tested
- Autogenic drainage, Intrapulmonary percussive ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainageDevice
The manual technique of the chest physiotherapy to move the secretions
Intrapulmonary percussive ventilationDevice
The instrumental technique of the chest physiotherapy to move the secretions
| Study group | Role | What they receive |
|---|---|---|
| Intubated infant | Experimental | Not described Receives: Device: Autogenic drainage; Device: Intrapulmonary percussive ventilation |
| Extubated infant | Experimental | Not described Receives: Device: Autogenic drainage; Device: Intrapulmonary percussive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Atelectasis scores at 20 min
Each atelectasis has a thoracic ultrasound
Measured: Baseline and at 20 min
Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Change from baseline respiratory frequency at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Change from baseline systolic blood pressure at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Change from baseline diastolic blood pressure at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Change from baseline expiratory CO2 at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Measured: Baseline and at 20 min, 30 min, 50 min, 80 min
Compare the atelectasis scores
Compare the atelectasis scores between thoracic ultrasound and chest x-ray
Measured: Baseline between thoracic ultrasound and chest x-ray
Secondary outcomes (1)
Number of unexpected events
Pain, desaturation, accidentally extubation
Measured: At 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start3 Apr 2007
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112811
- Sponsor's protocol ID
- Atelectasis001
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care
- ClinicalTrials.gov ID
- NCT03112811
- Acronym / sponsor ID
- Atelectasis001
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 3 Apr 2007 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 13 Apr 2017 (actual)
- 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.
The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubated infant | Experimental | Device: Autogenic drainage, Device: Intrapulmonary percussive ventilation |
| Extubated infant | Experimental | Device: Autogenic drainage, Device: Intrapulmonary percussive ventilation |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child < 10 kg
- Hospitalization in the pediatric intensive care
- Presence of an atelectasis to the radiography and/or to the lung ultrasound
- Presence of an invasive ventilation or a non-invasive ventilation
- Criteria of cardio-respiratory stability met
Key exclusion criteria (7 listed)
- Absence of the physiotherapist and the radiologist referents (by ex: at night)
- Prematurity
- Neuromuscular disease
- Ventilation by high-frequency oscillation
- Extraphysical Assistance
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 |
|---|---|---|
| Autogenic drainageThe manual technique of the chest physiotherapy to move the secretions | Device | Extubated infant, Intubated infant |
| Intrapulmonary percussive ventilationThe instrumental technique of the chest physiotherapy to move the secretions | Device | Extubated infant, Intubated infant |
Primary outcome
Change from baseline Atelectasis scores at 20 min
Time frame: Baseline and at 20 min
Each atelectasis has a thoracic ultrasound
Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Change from baseline respiratory frequency at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Change from baseline systolic blood pressure at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Change from baseline diastolic blood pressure at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Change from baseline expiratory CO2 at 20 min, 30 min, 50 min, 80 min
Time frame: Baseline and at 20 min, 30 min, 50 min, 80 min
Stability of the parameters
Compare the atelectasis scores
Time frame: Baseline between thoracic ultrasound and chest x-ray
Compare the atelectasis scores between thoracic ultrasound and chest x-ray
1 secondary outcome
Number of unexpected events
Time frame: At 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
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Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
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Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
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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.
Damien Moerman, PT contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic drainage and Intrapulmonary percussive ventilation in people with Atelectasis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2017. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Moerman, PT (damien.moerman@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Atelectasis scores at 20 min (time frame: Baseline and at 20 min). The study lists 8 primary outcomes in all. 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 13 Apr 2017.