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

NCT ID: NCT00355732

Last Updated: 2006-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

Respiratory Failure

Keywords

Respiration; COPD; Mechanical Ventilation; Ventilator Weaning; Respiratory Failure; ICU; Pressure Support Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Weaning from mechanical ventilation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: collaborator

Dr. Josip Benčević General Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Ivo Matić, MD PhD

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care, Dr. Josip Benčević General Hospital, Slavonski Brod, Croatia

Locations

Dr. Josip Benčević General Hospital

Slavonski Brod, , Croatia

Clinic Hospital Center Zagreb

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

123456

Identifier Type: -

Identifier Source: org_study_id