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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03112811
Other study ID # Atelectasis001
Secondary ID
Status Recruiting
Phase N/A
First received April 3, 2017
Last updated April 7, 2017
Start date April 3, 2007
Est. completion date January 1, 2021

Study information

Verified date April 2017
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Damien Moerman, PT
Email damien.moerman@uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Atelectasis scores at 20 min Each atelectasis has a thoracic ultrasound Baseline and at 20 min
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Compare the atelectasis scores Compare the atelectasis scores between thoracic ultrasound and chest x-ray Baseline between thoracic ultrasound and chest x-ray
Secondary Number of unexpected events Pain, desaturation, accidentally extubation At 20 min
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