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Clinical Trials/NCT01047852
NCT01047852
Completed
N/A

Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders

University Hospital, Bordeaux4 sites in 1 country144 target enrollmentJanuary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
University Hospital, Bordeaux
Enrollment
144
Locations
4
Primary Endpoint
Incidence of respiratory failure after extubation
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

Detailed Description

Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age \> 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score \> 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
August 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients intubated for 48 hours or more
  • Patients with Chronic respiratory disorders
  • And/or hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria

  • Face or cranial trauma or surgery
  • Home noninvasive ventilation
  • Recent gastric or oesophageal surgery
  • Tracheostomy or other upper airway disorders
  • Upper gastrointestinal bleeding
  • Excess respiratory secretions
  • Lack of collaboration
  • Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

Outcomes

Primary Outcomes

Incidence of respiratory failure after extubation

Time Frame: 2 days

Secondary Outcomes

  • Incidence of reintubation(2 months)
  • Length of stay in Intensive Care Unit(2 months)
  • Hospital mortality(2 months)
  • Survival(90th day)
  • Incidence of complications associated to mechanical ventilation(2 months)

Study Sites (4)

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