Noninvasive Ventilation After Extubation in Hypercapnic Patients (VHYPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047852
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Procedure: Noninvasive ventilation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NIV Procedure: Noninvasive ventilation
NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula

No Intervention: Control

Primary Outcome Measures :
  1. Incidence of respiratory failure after extubation [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Incidence of reintubation [ Time Frame: 2 months ]
  2. Length of stay in Intensive Care Unit [ Time Frame: 2 months ]
  3. Hospital mortality [ Time Frame: 2 months ]
  4. Survival [ Time Frame: 28th day ]
  5. Survival [ Time Frame: 90th day ]
  6. Incidence of complications associated to mechanical ventilation [ Time Frame: 2 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047852

Agen, France, 47923
Saint-André Hospital
Bordeaux, France, 33075
Pellegrin Hospital, Recovery Unit
Bordeaux, France, 33076
Libourne, France, 33505
University Hospital
Limoges, France, 87042
University Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Frédéric VARGAS, MD University Hospital, Bordeaux, France
Principal Investigator: Olivier GUISSET, MD University Hospital, Bordeaux, France
Principal Investigator: Marc CLAVEL, MD University Hospital, Limoges, France
Principal Investigator: Pascale SANCHEZ, MD University Hospital, Toulouse, France
Principal Investigator: Sylvain GARNIER, MD Hospital, Libourne, France
Principal Investigator: Aissa KHERCHACHE, MD Hospital, Agen, France
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux, France

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux Identifier: NCT01047852     History of Changes
Other Study ID Numbers: CHUBX 2009/10
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Bordeaux:
chronic respiratory disorders
hypercapnic respiratory failure
noninvasive ventilation

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