Viewing Study NCT00355732



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Study NCT ID: NCT00355732
Status: COMPLETED
Last Update Posted: 2006-10-26
First Post: 2006-07-23

Brief Title: Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients
Sponsor: Dr Josip Benčević General Hospital
Organization: Dr Josip Benčević General Hospital

Study Overview

Official Title: Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients Randomized Prospective Study
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 0001 whereas extubation failure was in 14 44 patients with T-tube and in 9 28 patients with PSV P 0001 Mechanical ventilation duration was 1867 h with T-tube and 1632 h with PSV P 0001 time spent in ICU was 2407 h with T-tube and 2102 h with PSV P 0001

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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None