Non-Invasive Ventilation After Extubation in Hypercapnic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Primary outcome: The incidence of respiratory failure after extubation
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Primary outcome: The incidence of respiratory failure after extubation
Time Frame: 3 days after extubation
Secondary Outcomes
- Survival(90 days)