Noninvasive Ventilation After Extubation in Hypercapnic Patients (VHYPER)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Noninvasive ventilation

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
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Agen, France, 47923
    • Hospital
  • Bordeaux, France, 33075
    • Saint-André Hospital
  • Bordeaux, France, 33076
    • Pellegrin Hospital, Recovery Unit
  • Libourne, France, 33505
    • Hospital
  • Limoges, France, 87042
    • University Hospital
  • Toulouse, France, 31059
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of respiratory failure after extubation	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: noninvasive ventilation; chronic respiratory disorders; hypercapnic respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: CHUBX 2009/10