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

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Acute Respiratory Insufficiency
• Intervention / Treatment: Procedure: MI-E plus manually assisted coughing; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of respiratory failure after extubation	48h post extubation (48h after inclusion)

Secondary Outcome Measures

Outcome Measure	Time Frame
the increase in peak cough flow	End of intensive care or day 28 after inclusion
the incidence of reintubation	End of intensive care or day 28 after inclusion
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
the number of additional physiotherapy sessions	End of intensive care or day 28 after inclusion
the ICU mortality or 28-day survival	28 days after inclusion
90 days survival	90 days after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine Bénard, MD, University Hospital, Bordeaux; Principal Investigator: Philippe WIBART, Physical therapist, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Intensive care unit; Respiratory failure; acute respiratory insufficiency; Mechanical Insufflation-Exsufflation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CHUBX 2011/21