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

University Hospital of Bordeaux

Status

Completed

Conditions

Acute Respiratory Insufficiency

Respiratory Failure

Treatments

Procedure: manually assisted coughing

Procedure: MI-E plus manually assisted coughing

Study type

Interventional

Funder types

Other

Identifiers

NCT01931228

CHUBX 2011/21

Details and patient eligibility

About

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

Full 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.

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.