Noninvasive Ventilation After Extubation in Hypercapnic Patients (VHYPER)
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring chronic respiratory disorders, hypercapnic respiratory failure, noninvasive ventilation
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.
Sites / Locations
- Hospital
- Saint-André Hospital
- Pellegrin Hospital, Recovery Unit
- Hospital
- University Hospital
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NIV
Control
Arm Description
Outcomes
Primary Outcome Measures
Incidence of respiratory failure after extubation
Secondary Outcome Measures
Incidence of reintubation
Length of stay in Intensive Care Unit
Hospital mortality
Survival
Survival
Incidence of complications associated to mechanical ventilation
Full Information
NCT ID
NCT01047852
First Posted
January 5, 2010
Last Updated
March 4, 2015
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01047852
Brief Title
Noninvasive Ventilation After Extubation in Hypercapnic Patients
Acronym
VHYPER
Official Title
Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
chronic respiratory disorders, hypercapnic respiratory failure, noninvasive ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIV
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Noninvasive ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of respiratory failure after extubation
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Incidence of reintubation
Time Frame
2 months
Title
Length of stay in Intensive Care Unit
Time Frame
2 months
Title
Hospital mortality
Time Frame
2 months
Title
Survival
Time Frame
28th day
Title
Survival
Time Frame
90th day
Title
Incidence of complications associated to mechanical ventilation
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric VARGAS, MD
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier GUISSET, MD
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc CLAVEL, MD
Organizational Affiliation
University Hospital, Limoges, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascale SANCHEZ, MD
Organizational Affiliation
University Hospital, Toulouse, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvain GARNIER, MD
Organizational Affiliation
Hospital, Libourne, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aissa KHERCHACHE, MD
Organizational Affiliation
Hospital, Agen, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital
City
Agen
ZIP/Postal Code
47923
Country
France
Facility Name
Saint-André Hospital
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Pellegrin Hospital, Recovery Unit
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospital
City
Libourne
ZIP/Postal Code
33505
Country
France
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28393258
Citation
Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.
Results Reference
derived
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Noninvasive Ventilation After Extubation in Hypercapnic Patients
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