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Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03112811
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Atelectasis Device: Autogenic drainage Device: Intrapulmonary percussive ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care
Actual Study Start Date : April 3, 2007
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Experimental: Intubated infant Device: Autogenic drainage
The manual technique of the chest physiotherapy to move the secretions

Device: Intrapulmonary percussive ventilation
The instrumental technique of the chest physiotherapy to move the secretions

Experimental: Extubated infant Device: Autogenic drainage
The manual technique of the chest physiotherapy to move the secretions

Device: Intrapulmonary percussive ventilation
The instrumental technique of the chest physiotherapy to move the secretions




Primary Outcome Measures :
  1. Change from baseline Atelectasis scores at 20 min [ Time Frame: Baseline and at 20 min ]
    Each atelectasis has a thoracic ultrasound

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. Number of unexpected events [ Time Frame: At 20 min ]
    Pain, desaturation, accidentally extubation



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112811


Contacts
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Contact: Damien Moerman, PT damien.moerman@uclouvain.be

Locations
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Belgium
Recruiting
Bruxelles, Belgium
Contact: Damien M Moerman, PT       damien.moerman@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03112811    
Other Study ID Numbers: Atelectasis001
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases