Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Respiratory Failure Clinical Trial

Official title:

Non-Invasive Ventilation After Extubation in Hypercapnic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539708
• Other study ID #: FIS 041130
• Status: Completed
• Phase: N/A
• First received: October 3, 2007
• Last updated: May 6, 2008
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: May 2008
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hypercapnia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Non-invasive ventilation
Non-invasive ventilation after extubation for 24 hours

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: The incidence of respiratory failure after extubation		3 days after extubation	No
Secondary	Survival		90 days	No