Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care

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.

Study Overview

• Status: Unknown
• Conditions: Atelectasis
• Intervention / Treatment: Device: Autogenic drainage; Device: Intrapulmonary percussive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Recruiting
    • Contact: Damien M Moerman, PT; Email: damien.moerman@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Atelectasis scores at 20 min	Each atelectasis has a thoracic ultrasound	Baseline and at 20 min
Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min	Stability of the parameters	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	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	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	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	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	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	Baseline between thoracic ultrasound and chest x-ray

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unexpected events	Pain, desaturation, accidentally extubation	At 20 min

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2007
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: Atelectasis001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No