Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03112811 |
Date of registration:
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03/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
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Scientific title:
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Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care |
Date of first enrolment:
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April 3, 2007 |
Target sample size:
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80 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03112811 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Damien M Moerman, PT |
Address:
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Telephone:
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Email:
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damien.moerman@uclouvain.be |
Affiliation:
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Name:
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Damien Moerman, PT |
Address:
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Telephone:
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Email:
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damien.moerman@uclouvain.be |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
N/A
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atelectasis
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Intervention(s)
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Device: Intrapulmonary percussive ventilation
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Device: Autogenic drainage
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Primary Outcome(s)
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Change from baseline Atelectasis scores at 20 min
[Time Frame: Baseline and at 20 min]
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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]
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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]
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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]
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Compare the atelectasis scores
[Time Frame: Baseline between thoracic ultrasound and chest x-ray]
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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]
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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]
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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]
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Secondary Outcome(s)
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Number of unexpected events
[Time Frame: At 20 min]
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Secondary ID(s)
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Atelectasis001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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