Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care

• ClinicalTrials.gov Identifier: NCT03112811
• Recruitment Status: Recruiting
• First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Information provided by (Responsible Party): Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

Belgium

Recruiting

Bruxelles, Belgium

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

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

More Information

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT03112811
• Other Study ID Numbers: Atelectasis001
• First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pulmonary Atelectasis; Lung Diseases; Respiratory Tract Diseases