VHYPER: Noninvasive Ventilation After Extubation in Hypercapnic Patients

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01047852

Collaborator

(none)

144

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of respiratory failure after extubation [2 days]

Secondary Outcome Measures

Incidence of reintubation [2 months]
Length of stay in Intensive Care Unit [2 months]
Hospital mortality [2 months]
Survival [28th day]
Survival [90th day]
Incidence of complications associated to mechanical ventilation [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital	Agen	France	47923
2	Saint-André Hospital	Bordeaux	France	33075
3	Pellegrin Hospital, Recovery Unit	Bordeaux	France	33076
4	Hospital	Libourne	France	33505
5	University Hospital	Limoges	France	87042
6	University Hospital	Toulouse	France	31059

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

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