NCT03112811

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2007

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

13.8 years

First QC Date

April 3, 2017

Last Update Submit

April 7, 2017

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Number of unexpected events

    At 20 min

Study Arms (2)

Intubated infant

EXPERIMENTAL
Device: Autogenic drainageDevice: Intrapulmonary percussive ventilation

Extubated infant

EXPERIMENTAL
Device: Autogenic drainageDevice: Intrapulmonary percussive ventilation

Interventions

Autogenic drainageDEVICE

The manual technique of the chest physiotherapy to move the secretions

Extubated infantIntubated infant
Intrapulmonary percussive ventilationDEVICE

The instrumental technique of the chest physiotherapy to move the secretions

Extubated infantIntubated infant

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Damien Moerman, PT

CONTACT

damien.moerman@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 13, 2017

Study Start

April 3, 2007

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)