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Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

NCT03316079 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-10-20

No results posted yet for this study

Summary

Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation.

Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.

Conditions

  • Mucus Retention
  • Mechanical Ventilation Complication
  • Mucus; Plug, Tracheobronchial

Interventions

OTHER

Chest physiotherapy techniques

Respiratory manual CPT

DEVICE

Mechanical insufflation-exsufflation

CPT + MI-E (4 series of 5 inspiratory-expiratory cycles at +/- 40 cmH2O, 3 seconds of inspiratory time, 2 seconds of expiratory time and 1 second pause between cycles).

Sponsors & Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

    collaborator OTHER

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Roberto Martinez Alejos, Msc · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-06
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316079 on ClinicalTrials.gov