Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
Primary Purpose
Atelectasis
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Autogenic drainage
Intrapulmonary percussive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis
Eligibility Criteria
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
Sites / Locations
- Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intubated infant
Extubated infant
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline Atelectasis scores at 20 min
Each atelectasis has a thoracic ultrasound
Change from baseline cardiac frequency 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
Stability of the parameters
Change from baseline systolic blood pressure 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
Stability of the parameters
Change from baseline oxygen saturation 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
Stability of the parameters
Compare the atelectasis scores
Compare the atelectasis scores between thoracic ultrasound and chest x-ray
Secondary Outcome Measures
Number of unexpected events
Pain, desaturation, accidentally extubation
Full Information
NCT ID
NCT03112811
First Posted
April 3, 2017
Last Updated
April 7, 2017
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03112811
Brief Title
Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
Official Title
Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2007 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intubated infant
Arm Type
Experimental
Arm Title
Extubated infant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Autogenic drainage
Intervention Description
The manual technique of the chest physiotherapy to move the secretions
Intervention Type
Device
Intervention Name(s)
Intrapulmonary percussive ventilation
Intervention Description
The instrumental technique of the chest physiotherapy to move the secretions
Primary Outcome Measure Information:
Title
Change from baseline Atelectasis scores at 20 min
Description
Each atelectasis has a thoracic ultrasound
Time Frame
Baseline and at 20 min
Title
Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Change from baseline respiratory frequency at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Change from baseline systolic blood pressure at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Change from baseline diastolic blood pressure at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Change from baseline expiratory CO2 at 20 min, 30 min, 50 min, 80 min
Description
Stability of the parameters
Time Frame
Baseline and at 20 min, 30 min, 50 min, 80 min
Title
Compare the atelectasis scores
Description
Compare the atelectasis scores between thoracic ultrasound and chest x-ray
Time Frame
Baseline between thoracic ultrasound and chest x-ray
Secondary Outcome Measure Information:
Title
Number of unexpected events
Description
Pain, desaturation, accidentally extubation
Time Frame
At 20 min
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damien Moerman, PT
Email
damien.moerman@uclouvain.be
Facility Information:
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien M Moerman, PT
Email
damien.moerman@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
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