Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Hospital Clinic of Barcelona

Status: Completed

Conditions: Respiratory Failure

Treatments: Procedure: Non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00539708

FIS 041130

Details and patient eligibility

About

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.

Full 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).

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

NIV

Experimental group

Description:

Non-invasive ventilation

Treatment:

Procedure: Non-invasive ventilation

Control

Active Comparator group

Description:

Oxygen therapy

Treatment:

Procedure: Non-invasive ventilation