Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: Non-invasive ventilation

• Registration Number: NCT00539708
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

Detailed Description

Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients. Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 \>45 mmHg) during the spontaneous breathing trial, ready to be extubated. Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management. Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay). Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Chronic respiratory disorders with invasive mechanical ventilation
• Hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria

• Face or cranial trauma or surgery
• Recent gastric or esophageal surgery
• Tracheostomy or other upper airway disorders
• Upper gastrointestinal bleeding
• Excess respiratory secretions
• Lack of collaboration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV	Non-invasive ventilation	Non-invasive ventilation
Control	Non-invasive ventilation	Oxygen therapy

Primary Outcome Measures

Name	Time	Method
Primary outcome: The incidence of respiratory failure after extubation	3 days after extubation

Secondary Outcome Measures

Name	Time	Method
Survival	90 days

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain