Clinical trial NCT01047852: Noninvasive Ventilation After Extubation in Hypercapnic Patients
Official title: Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: chronic respiratory disorders
hypercapnic respiratory failure
noninvasive ventilation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of respiratory failure after extubation
timeFrame: 2 days
Secondary outcomes:
measure: Incidence of reintubation
timeFrame: 2 months
measure: Length of stay in Intensive Care Unit
timeFrame: 2 months
measure: Hospital mortality
timeFrame: 2 months
measure: Survival
timeFrame: 28th day
measure: Survival
timeFrame: 90th day
measure: Incidence of complications associated to mechanical ventilation
timeFrame: 2 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Hospital
city: Bordeaux
country: France
facility: Saint-André Hospital
city: Bordeaux
country: France
facility: Pellegrin Hospital, Recovery Unit
city: Libourne
country: France
facility: Hospital
city: Limoges
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Frédéric VARGAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux, France
name: Olivier GUISSET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Limoges, France
name: Marc CLAVEL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse, France
name: Pascale SANCHEZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital, Libourne, France
name: Sylvain GARNIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital, Agen, France
name: Aissa KHERCHACHE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux, France
name: Antoine BENARD, MD
role: STUDY_CHAIR
References:
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.