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Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-invasive ventilation
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring Non-invasive ventilation, Hypercapnic respiratory failure, Mechanical ventilation, Respiratory failure after extubation

Eligibility Criteria

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

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

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIV

Control

Arm Description

Non-invasive ventilation

Oxygen therapy

Outcomes

Primary Outcome Measures

Primary outcome: The incidence of respiratory failure after extubation

Secondary Outcome Measures

Survival

Full Information

First Posted
October 3, 2007
Last Updated
May 6, 2008
Sponsor
Hospital Clinic of Barcelona
Collaborators
Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT00539708
Brief Title
Non-Invasive Ventilation After Extubation in Hypercapnic Patients
Official Title
Non-Invasive Ventilation After Extubation in Hypercapnic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Non-invasive ventilation, Hypercapnic respiratory failure, Mechanical ventilation, Respiratory failure after extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIV
Arm Type
Experimental
Arm Description
Non-invasive ventilation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
Non-invasive ventilation
Intervention Description
Non-invasive ventilation after extubation for 24 hours
Primary Outcome Measure Information:
Title
Primary outcome: The incidence of respiratory failure after extubation
Time Frame
3 days after extubation
Secondary Outcome Measure Information:
Title
Survival
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miquel Ferrer, MD, PhD
Organizational Affiliation
UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19682735
Citation
Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.
Results Reference
derived

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Non-Invasive Ventilation After Extubation in Hypercapnic Patients

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