Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy (NEUROMIE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01931228|
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : January 23, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Insufficiency Respiratory Failure||Procedure: MI-E plus manually assisted coughing Procedure: manually assisted coughing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy|
|Actual Study Start Date :||May 3, 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2016|
|Experimental: MI-E plus manually assisted coughing||
Procedure: MI-E plus manually assisted coughing
MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
|Experimental: Manually assisted coughing only||
Procedure: manually assisted coughing
Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
- Incidence of respiratory failure after extubation [ Time Frame: 48h post extubation (48h after inclusion) ]
- the increase in peak cough flow [ Time Frame: End of intensive care or day 28 after inclusion ]
- the incidence of reintubation [ Time Frame: End of intensive care or day 28 after inclusion ]
- the average time of hospitalization in the intensive care unit [ Time Frame: End of intensive care or day 28 after inclusion ]
- the incidence of nasotracheal suction [ Time Frame: End of intensive care or day 28 after inclusion ]
- the number of additional physiotherapy sessions [ Time Frame: End of intensive care or day 28 after inclusion ]
- the ICU mortality or 28-day survival [ Time Frame: 28 days after inclusion ]
- 90 days survival [ Time Frame: 90 days after inclusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931228
|CHU de Bordeaux|
|Bordeaux, France, 33000|
|Principal Investigator:||Philippe WIBART, Physical therapist||University Hospital, Bordeaux|
|Study Chair:||Antoine BENARD, MD||University Hospital, Bordeaux|