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

Respiratory Failure Clinical Trial

— NEUROMIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931228
• Other study ID #: CHUBX 2011/21
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: January 19, 2018
• Start date: May 3, 2012
• Est. completion date: May 2016

Study information

• Verified date: January 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: May 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Neuromuscular Diseases
• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of respiratory failure after extubation		48h post extubation (48h after inclusion)
Secondary	the increase in peak cough flow		End of intensive care or day 28 after inclusion
Secondary	the incidence of reintubation		End of intensive care or day 28 after inclusion
Secondary	the average time of hospitalization in the intensive care unit		End of intensive care or day 28 after inclusion
Secondary	the incidence of nasotracheal suction		End of intensive care or day 28 after inclusion
Secondary	the number of additional physiotherapy sessions		End of intensive care or day 28 after inclusion
Secondary	the ICU mortality or 28-day survival		28 days after inclusion
Secondary	90 days survival		90 days after inclusion