ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Acute Respiratory Insufficiency Respiratory Failure Procedure: MI-E plus manually assisted coughing Procedure: manually assisted coughing Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Incidence of respiratory failure after extubation [ Time Frame: 48h post extubation (48h after inclusion) ]

Secondary Outcome Measures :
  1. the increase in peak cough flow [ Time Frame: End of intensive care or day 28 after inclusion ]
  2. the incidence of reintubation [ Time Frame: End of intensive care or day 28 after inclusion ]
  3. the average time of hospitalization in the intensive care unit [ Time Frame: End of intensive care or day 28 after inclusion ]
  4. the incidence of nasotracheal suction [ Time Frame: End of intensive care or day 28 after inclusion ]
  5. the number of additional physiotherapy sessions [ Time Frame: End of intensive care or day 28 after inclusion ]
  6. the ICU mortality or 28-day survival [ Time Frame: 28 days after inclusion ]
  7. 90 days survival [ Time Frame: 90 days after inclusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patient aged ≥ 18 years.
  • Patient admitted in participant ICU.
  • Patient intubated for 48 hours at least.
  • Patient presenting an ICU acquired neuromuscular disorders.

Exclusion criteria:

  • Respiratory or haemodynamic instability.
  • Patient having a contraindication to use face mask (Recent facial surgery, severe craniofacial trauma,…) gastroesophageal surgery.
  • Severe ventricular rhythm disorders.
  • Patient with tracheotomy.
  • Uncontrollable vomiting.
  • Severe sepsis.
  • Upper airway disorders.
  • Upper gastrointestinal bleeding.
  • Any decision to limit therapeutic effort in the ICU.
  • Patient with limit therapeutic effort in the ICU with unsuccessful spontaneous respiratory trial.

Information from the National Library of Medicine

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


Locations
France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Philippe WIBART, Physical therapist University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01931228     History of Changes
Other Study ID Numbers: CHUBX 2011/21
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by University Hospital, Bordeaux:
Intensive care unit
acute respiratory insufficiency
Respiratory failure
Mechanical Insufflation-Exsufflation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases