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

Ventilatory Failure Clinical Trial

— MIEICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424202
• Other study ID #: MIEICU-08112010
• Status: Completed
• Phase: N/A
• First received: August 25, 2011
• Last updated: August 25, 2011
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: Hospital Sao Joao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypoventilation
• Persistent Weaning Failure
• Post-extubation Failure
• Respiratory Insufficiency
• Secretion Encumbrance
• Ventilatory Failure
• Weak Cough

Intervention

Device:
• Mechanical Insufflation Exsufflation
After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle. On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions. The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.

Locations

Country	Name	City	State
Portugal	Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Joao

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguía C, González M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alía I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	re-intubation rates		48 hours	No
Secondary	NIV failure rates		48 hours	No