Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy

Not Applicable

Completed

• Conditions: Acute Respiratory Insufficiency; Respiratory Failure
• Interventions: Procedure: MI-E plus manually assisted coughing; Procedure: manually assisted coughing

• Registration Number: NCT01931228
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.

the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing

Detailed Description

Critical Care Neuromyopathy (CCN) occur in 25% of patient in Intensive Care Unit (ICU). Respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. Respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. Currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. Despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. MI-E has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. So the beneficials effects of MI-E should be confirmed in a trial in this specific population.

We planned to conduct a study evaluating the efficacy of MI-E in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to MI-E group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU or 28-day survival,90-day survival, ICU length of stay.

Study Timeline

• Study Start: 2012-05-03
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-29
• Primary Completion: 2015-02
• Study Completion: 2016-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MI-E plus manually assisted coughing	MI-E plus manually assisted coughing	-
Manually assisted coughing only	manually assisted coughing	-

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory failure after extubation	48h post extubation (48h after inclusion)

Secondary Outcome Measures

Name	Time	Method
the average time of hospitalization in the intensive care unit	End of intensive care or day 28 after inclusion
the incidence of nasotracheal suction	End of intensive care or day 28 after inclusion
90 days survival	90 days after inclusion
the number of additional physiotherapy sessions	End of intensive care or day 28 after inclusion
the increase in peak cough flow	End of intensive care or day 28 after inclusion
the ICU mortality or 28-day survival	28 days after inclusion
the incidence of reintubation	End of intensive care or day 28 after inclusion

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France