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

Primary Purpose

Acute Respiratory Insufficiency, Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MI-E plus manually assisted coughing
manually assisted coughing
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Insufficiency focused on measuring Intensive care unit, acute respiratory insufficiency, Respiratory failure, Mechanical Insufflation-Exsufflation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MI-E plus manually assisted coughing

Manually assisted coughing only

Arm Description

Outcomes

Primary Outcome Measures

Incidence of respiratory failure after extubation

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2013
Last Updated
January 19, 2018
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01931228
Brief Title
Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy
Acronym
NEUROMIE
Official Title
Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 3, 2012 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Insufficiency, Respiratory Failure
Keywords
Intensive care unit, acute respiratory insufficiency, Respiratory failure, Mechanical Insufflation-Exsufflation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI-E plus manually assisted coughing
Arm Type
Experimental
Arm Title
Manually assisted coughing only
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MI-E plus manually assisted coughing
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
manually assisted coughing
Intervention Description
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 Measure Information:
Title
Incidence of respiratory failure after extubation
Time Frame
48h post extubation (48h after inclusion)
Secondary Outcome Measure Information:
Title
the increase in peak cough flow
Time Frame
End of intensive care or day 28 after inclusion
Title
the incidence of reintubation
Time Frame
End of intensive care or day 28 after inclusion
Title
the average time of hospitalization in the intensive care unit
Time Frame
End of intensive care or day 28 after inclusion
Title
the incidence of nasotracheal suction
Time Frame
End of intensive care or day 28 after inclusion
Title
the number of additional physiotherapy sessions
Time Frame
End of intensive care or day 28 after inclusion
Title
the ICU mortality or 28-day survival
Time Frame
28 days after inclusion
Title
90 days survival
Time Frame
90 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe WIBART, Physical therapist
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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

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