Non-Invasive Ventilation After Extubation in Hypercapnic Patients
May 6, 2008 updated by: Hospital Clinic of Barcelona
The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality.
We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients.
Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group).
Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 >45 mmHg) during the spontaneous breathing trial, ready to be extubated.
Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management.
Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay).
Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
-
Barcelona, Spain, 08036
- Hospital Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic respiratory disorders with invasive mechanical ventilation
- Hypercapnic respiratory failure during successful spontaneous breathing trial
Exclusion Criteria:
- Face or cranial trauma or surgery
- Recent gastric or esophageal surgery
- Tracheostomy or other upper airway disorders
- Upper gastrointestinal bleeding
- Excess respiratory secretions
- Lack of collaboration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NIV
Non-invasive ventilation
|
Non-invasive ventilation after extubation for 24 hours
|
|
Active Comparator: Control
Oxygen therapy
|
Non-invasive ventilation after extubation for 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary outcome: The incidence of respiratory failure after extubation
Time Frame: 3 days after extubation
|
3 days after extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Survival
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Miquel Ferrer, MD, PhD, UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
October 3, 2007
First Submitted That Met QC Criteria
October 3, 2007
First Posted (Estimate)
October 4, 2007
Study Record Updates
Last Update Posted (Estimate)
May 12, 2008
Last Update Submitted That Met QC Criteria
May 6, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS 041130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.