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| Sponsor: | Hospital Clinic of Barcelona |
|---|---|
| Collaborator: |
Fondo de Investigacion Sanitaria |
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00539708 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Failure |
Procedure: Non-invasive ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Non-Invasive Ventilation After Extubation in Hypercapnic Patients |
| Enrollment: | 106 |
| Study Start Date: | May 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NIV
Non-invasive ventilation
|
Procedure: Non-invasive ventilation
Non-invasive ventilation after extubation for 24 hours
|
|
Active Comparator: Control
Oxygen therapy
|
Procedure: Non-invasive ventilation
Non-invasive ventilation after extubation for 24 hours
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clinic | |
| Barcelona, Spain, 08036 | |
| Principal Investigator: | Miquel Ferrer, MD, PhD | UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona |
More Information
| Responsible Party: | Miquel Ferrer, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00539708 History of Changes |
| Other Study ID Numbers: | FIS 041130 |
| Study First Received: | October 3, 2007 |
| Last Updated: | May 6, 2008 |
| Health Authority: | Spain: Ministry of Health and Consumption |
|
Non-invasive ventilation Hypercapnic respiratory failure Mechanical ventilation Respiratory failure after extubation |
|
Hypercapnia Respiratory Insufficiency Signs and Symptoms, Respiratory |
Signs and Symptoms Respiration Disorders Respiratory Tract Diseases |