Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients

Sponsor

Dr. Josip Benčević General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00355732

Collaborator

University of Zagreb (Other)

Locations

Study Details

Study Description

Brief Summary

To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Procedure: Weaning from mechanical ventilation	Phase 4

Detailed Description

A prospective, randomized trial was performed in a multidisciplinary Intensive Care Unit (ICU) for the duration of 2 years. A total of 136 COPD patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. After fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either T-tube or pressure support ventilation (PSV). The patients with successful 2-h trial were extubated and were excluded from further research. Patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. In these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome.

31 (47%) patient with T-tube and 32 (46%) patients with PSV had 2-h trial failure. Of those patients, successful extubation was in 17 (56%) patients with T-tube and in 23 (72%) with PSV (P <0.001), whereas extubation failure was in 14 (44%) patients with T-tube and in 9 (28%) patients with PSV (P <0.001). Mechanical ventilation duration was 186.7 h with T-tube and 163.2 h with PSV (P <0.001), time spent in ICU was 240.7 h with T-tube and 210.2 h with PSV (P <0.001).

In patients with COPD who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of PSV method was confirmed.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients; Randomized Prospective Study

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COPD
exacerbation of dyspnea <2 weeks
signs of respiratory muscle dysfunction

Exclusion Criteria:

non COPD patients
age <18 years
tracheotomy
MV duration shorter than 24h
use of MV on admission to the ICU or transfer to some other ICU for treatment continuation
patients who died or weaning from MV was discontinued because of another associated disorder
central nerve system disorders unrelated to hypercapnic encephalopathy or hypoxemia
cardiac arrest within 5 days
patients scheduled for organ donation