NCT03316079

Efficacity and Safety of Mechanical Insufflation-exsufflation on ICU

Status unknown NA Last updated 20 October 2017

What this trial tests

NA trial testing Chest physiotherapy techniques in Mucus Retention in 26 participants. Status unknown.

Timeline

6 March 2015

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	26
Start date	6 March 2015
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	3 locations across France

Drugs / interventions tested

• Chest physiotherapy techniques
• Mechanical insufflation-exsufflation

Conditions studied

• Mucus Retention — all drugs for Mucus Retention →
• Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
• Mucus; Plug, Tracheobronchial — all drugs for Mucus; Plug, Tracheobronchial →

Sponsor

University Hospital, Bordeaux

Who can join

Adults 18 to 90, any sex, with Mucus Retention or Mechanical Ventilation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects.
   Martínez-Alejos R, Martí JD, Li Bassi G, Gonzalez-Anton D, et al · · 2021 · cited 15× · PMID 34103385 · DOI 10.4187/respcare.08641
2. Effects Of Mechanical In-Exsufflation On Mucus Clearance In Critically Ill Patients On Invasive Mechanical Ventilation
   Martinez-Alejos R, Martí J, Bassi GL, Gonzalez-Anton D, et al · · 2020 · DOI 10.21203/rs.3.rs-52429/v1