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

NCT01424202 | Completed

• 1 other identifier: MIEICU-08112010
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Post extubation failure; Mechanical Insufflation-Exsufflation; Noninvasive Ventilation; Weaning

Outcome Measures

Primary Outcomes (1)

• re-intubation rates

  48 hours

Secondary Outcomes (1)

• NIV failure rates

  48 hours

Study Arms (2)

Group B

EXPERIMENTAL

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

Device: Mechanical Insufflation Exsufflation

Group A

NO INTERVENTION

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

Interventions

Mechanical Insufflation Exsufflation DEVICE

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sao Joao: lead

Study Sites (1)

Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João

Porto, Porto District, 4200-319, Portugal

Location

Related Publications (1)

• Esteban A, Frutos-Vivar F, Ferguson ND, Arabi Y, Apezteguia C, Gonzalez M, Epstein SK, Hill NS, Nava S, Soares MA, D'Empaire G, Alia I, Anzueto A. Noninvasive positive-pressure ventilation for respiratory failure after extubation. N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.

  PMID: 15190137 RESULT

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 26, 2011
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

PT (1)