Noninvasive Ventilation After Extubation in Hypercapnic Patients (VHYPER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01047852
First received: January 5, 2010
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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 Intervention
Respiratory Failure
Procedure: Noninvasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Incidence of respiratory failure after extubation [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of reintubation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Length of stay in Intensive Care Unit [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 28th day ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 90th day ] [ Designated as safety issue: No ]
  • Incidence of complications associated to mechanical ventilation [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047852

Locations
France
Hospital
Agen, France, 47923
Pellegrin Hospital, Recovery Unit
Bordeaux, France, 33076
Saint-André Hospital
Bordeaux, France, 33075
Hospital
Libourne, France, 33505
University Hospital
Limoges, France, 87042
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
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01047852     History of Changes
Other Study ID Numbers: CHUBX 2009/10
Study First Received: January 5, 2010
Last Updated: October 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 21, 2014