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Clinical Trials/NCT01931228
NCT01931228
Completed
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country123 target enrollmentMay 3, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Insufficiency
Sponsor
University Hospital, Bordeaux
Enrollment
123
Locations
1
Primary Endpoint
Incidence of respiratory failure after extubation
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2012
End Date
May 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of respiratory failure after extubation

Time Frame: 48h post extubation (48h after inclusion)

Secondary Outcomes

  • 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)

Study Sites (1)

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