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

Primary Purpose

Post-extubation Failure, Persistent Weaning Failure, Secretion Encumbrance

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Mechanical Insufflation Exsufflation
Sponsored by
Hospital Sao Joao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-extubation Failure focused on measuring Post extubation failure, Mechanical Insufflation-Exsufflation, Noninvasive Ventilation, Weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group B

Group A

Arm 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).

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

Outcomes

Primary Outcome Measures

re-intubation rates

Secondary Outcome Measures

NIV failure rates

Full Information

First Posted
August 25, 2011
Last Updated
August 25, 2011
Sponsor
Hospital Sao Joao
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1. Study Identification

Unique Protocol Identification Number
NCT01424202
Brief Title
Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
Acronym
MIEICU
Official Title
Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sao Joao

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-extubation Failure, Persistent Weaning Failure, Secretion Encumbrance, Weak Cough, Ventilatory Failure
Keywords
Post extubation failure, Mechanical Insufflation-Exsufflation, Noninvasive Ventilation, Weaning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Experimental
Arm 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).
Arm Title
Group A
Arm Type
No Intervention
Arm Description
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications.
Intervention Type
Device
Intervention Name(s)
Mechanical Insufflation Exsufflation
Intervention Description
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.
Primary Outcome Measure Information:
Title
re-intubation rates
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
NIV failure rates
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
15190137
Citation
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.
Results Reference
result

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

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