Noninvasive Ventilation After Extubation in Hypercapnic Patients

Respiratory Failure Clinical Trial

— VHYPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047852
• Other study ID #: CHUBX 2009/10
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: March 4, 2015
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercapnia
• Respiration Disorders
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hospital	Agen
France	Pellegrin Hospital, Recovery Unit	Bordeaux
France	Saint-André Hospital	Bordeaux
France	Hospital	Libourne
France	University Hospital	Limoges
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of respiratory failure after extubation		2 days	No
Secondary	Incidence of reintubation		2 months	No
Secondary	Length of stay in Intensive Care Unit		2 months	No
Secondary	Hospital mortality		2 months	No
Secondary	Survival		28th day	No
Secondary	Survival		90th day	No
Secondary	Incidence of complications associated to mechanical ventilation		2 months	No