Non-Invasive Ventilation After Extubation in Hypercapnic Patients

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00539708
First received: October 3, 2007
Last updated: May 6, 2008
Last verified: May 2008
  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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Primary outcome: The incidence of respiratory failure after extubation [ Time Frame: 3 days after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 90 days ] [ Designated as safety issue: No ]

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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539708

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Miquel Ferrer, MD, PhD UVIIR. Servei de Pneumologia, Hospital Clinic,Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Hospital Clinic of Barcelona:
Non-invasive ventilation
Hypercapnic respiratory failure
Mechanical ventilation
Respiratory failure after extubation

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014