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

NCT ID: NCT01931228

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-03
• Study Completion Date: 2016-05-31

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.

Conditions

Acute Respiratory Insufficiency; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MI-E plus manually assisted coughing

Group Type: EXPERIMENTAL

MI-E plus manually assisted coughing

Intervention Type: PROCEDURE

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 only

Group Type: EXPERIMENTAL

manually assisted coughing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe WIBART, Physical therapist

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Antoine BENARD, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

References

Wibart P, Reginault T, Garcia-Fontan M, Barbrel B, Bader C, Benard A, Parreira VF, Gonzalez-Anton D, Bui NH, Gruson D, Hilbert G, Martinez-Alejos R, Vargas F. Effects of mechanical in-exsufflation in preventing postextubation acute respiratory failure in intensive care acquired weakness patients: a randomized controlled trial. Crit Care Sci. 2023 Apr-Jun;35(2):168-176. doi: 10.5935/2965-2774.20230410-en.

Reference Type: DERIVED

PMID: 37712806 (View on PubMed)

Other Identifiers

CHUBX 2011/21

Identifier Type: -

Identifier Source: org_study_id