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

University Hospital Center of São João

Status: Completed

Conditions: Ventilatory Failure; Persistent Weaning Failure; Post-extubation Failure; Secretion Encumbrance; Weak Cough

Treatments: Device: Mechanical Insufflation Exsufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT01424202

MIEICU-08112010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Group B

Experimental group

Description:

Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E).

Treatment:

Device: Mechanical Insufflation Exsufflation

Group A

No Intervention group

Description:

Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications.