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

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ClinicalTrials.gov Identifier: NCT00355732
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : October 26, 2006
Sponsor:
Collaborator:
University of Zagreb
Information provided by:
Dr. Josip Benčević General Hospital

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.

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Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355732


Locations
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Croatia
Dr. Josip Benčević General Hospital
Slavonski Brod, Croatia, 35000
Clinic Hospital Center Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Dr. Josip Benčević General Hospital
University of Zagreb
Investigators
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Study Chair: Ivo Matić, MD PhD Department of Anesthesiology and Intensive Care, Dr. Josip Benčević General Hospital, Slavonski Brod, Croatia
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ClinicalTrials.gov Identifier: NCT00355732    
Other Study ID Numbers: 123456
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: July 2006
Keywords provided by Dr. Josip Benčević General Hospital:
Respiration
COPD
Mechanical Ventilation
Ventilator Weaning
Respiratory Failure
ICU
Pressure Support Ventilation
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders