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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01931228
First received: August 22, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention
Acute Respiratory Insufficiency
Respiratory Failure
Procedure: MI-E plus manually assisted coughing
Procedure: manually assisted coughing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Incidence of respiratory failure after extubation [ Time Frame: 48h post extubation (48h after inclusion) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the increase in peak cough flow [ Time Frame: End of intensive care or day 28 after inclusion ] [ Designated as safety issue: No ]
  • the incidence of reintubation [ Time Frame: End of intensive care or day 28 after inclusion ] [ Designated as safety issue: No ]
  • the average time of hospitalization in the intensive care unit [ Time Frame: End of intensive care or day 28 after inclusion ] [ Designated as safety issue: No ]
  • the incidence of nasotracheal suction [ Time Frame: End of intensive care or day 28 after inclusion ] [ Designated as safety issue: No ]
  • the number of additional physiotherapy sessions [ Time Frame: End of intensive care or day 28 after inclusion ] [ Designated as safety issue: No ]
  • the ICU mortality or 28-day survival [ Time Frame: 28 days after inclusion ] [ Designated as safety issue: Yes ]
  • 90 days survival [ Time Frame: 90 days after inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931228

Contacts
Contact: Philipppe Wibar, Physical therapist philippe.wibart@chu-bordeaux.fr
Contact: Marie-Pierre BAUDIER, CRA marie-pierre.baudier@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Philippe WIBART, Physical therapist         
Contact: Marie-Pierre BAUDIER, CRA         
Principal Investigator: Philippe WIBART, Physical Therapist         
Sub-Investigator: Bérangère BARBREL, Physical therapist         
Sub-Investigator: Alexandre BOYER, MD         
Sub-Investigator: Hoang-Nam BUI, MD         
Sub-Investigator: Benjamin CLOUZEAU, MD         
Sub-Investigator: Valérie FORTABAT, Physical Therapist         
Sub-Investigator: Yvette FOUSSATS, MD         
Sub-Investigator: Margarita GARCIA FONTAN, Physical Therapist         
Sub-Investigator: Didier GRUSON, MD - PhD         
Sub-Investigator: Anne-Claire GUEPIN, Physical Therapist         
Sub-Investigator: Gilles HILBERT, MD-PhD         
Sub-Investigator: Christophe LARRALDE, Physical Therapist         
Sub-Investigator: Thomas REGINAULT, Physical Therapist         
Sub-Investigator: Frédéric VARGAS, MD-PhD         
Sub-Investigator: Emmanuelle BERTEAU, Physical Therapist         
Sub-Investigator: Sylvie TAVENAS, Physical Therapist         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Philippe WIBART, Physical therapist Bordeaux University Hospital
Study Chair: Antoine BENARD, MD Bordeaux University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01931228     History of Changes
Other Study ID Numbers: CHUBX 2011/21
Study First Received: August 22, 2013
Last Updated: April 1, 2014
Health Authority: France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Neuromuscular Diseases
Respiratory Insufficiency
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014