Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Weaning from mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Respiration, COPD, Mechanical Ventilation, Ventilator Weaning, Respiratory Failure, ICU, Pressure Support Ventilation
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
Sites / Locations
- Dr. Josip Benčević General Hospital
- Clinic Hospital Center Zagreb
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00355732
First Posted
July 23, 2006
Last Updated
October 25, 2006
Sponsor
Dr. Josip Benčević General Hospital
Collaborators
University of Zagreb
1. Study Identification
Unique Protocol Identification Number
NCT00355732
Brief Title
Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients
Official Title
Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients; Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Dr. Josip Benčević General Hospital
Collaborators
University of Zagreb
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Respiration, COPD, Mechanical Ventilation, Ventilator Weaning, Respiratory Failure, ICU, Pressure Support Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Weaning from mechanical ventilation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivo Matić, MD PhD
Organizational Affiliation
Department of Anesthesiology and Intensive Care, Dr. Josip Benčević General Hospital, Slavonski Brod, Croatia
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Josip Benčević General Hospital
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Facility Name
Clinic Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Learn more about this trial
Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients
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