Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation

Not Applicable

Completed

• Conditions: Post-extubation Failure; Persistent Weaning Failure; Secretion Encumbrance; Weak Cough; Ventilatory Failure
• Interventions: Device: Mechanical Insufflation Exsufflation

• Registration Number: NCT01424202
• Lead Sponsor: Hospital Sao Joao

Brief Summary

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

Detailed Description

Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-26
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion Criteria

• facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group B	Mechanical Insufflation Exsufflation	Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E).

Primary Outcome Measures

Name	Time	Method
re-intubation rates	48 hours

Secondary Outcome Measures

Name	Time	Method
NIV failure rates	48 hours

Trial Locations

Locations (1)

Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João; 🇵🇹 Porto, Portugal