Clinical trial NCT01931228: Mechanical Insufflation-Exsufflation in Preventing Post Extubation Respiratory Failure in Patient With Critical Care Neuromyopathy
Official title: Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Insufficiency
Respiratory Failure
Keywords: Intensive care unit
acute respiratory insufficiency
Respiratory failure
Mechanical Insufflation-Exsufflation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Incidence of respiratory failure after extubation
timeFrame: 48h post extubation (48h after inclusion)
Secondary outcomes:
measure: the increase in peak cough flow
timeFrame: End of intensive care or day 28 after inclusion
measure: the incidence of reintubation
timeFrame: End of intensive care or day 28 after inclusion
measure: the average time of hospitalization in the intensive care unit
timeFrame: End of intensive care or day 28 after inclusion
measure: the incidence of nasotracheal suction
timeFrame: End of intensive care or day 28 after inclusion
measure: the number of additional physiotherapy sessions
timeFrame: End of intensive care or day 28 after inclusion
measure: the ICU mortality or 28-day survival
timeFrame: 28 days after inclusion
measure: 90 days survival
timeFrame: 90 days after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Philippe WIBART, Physical therapist
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: