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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00852891
Other study ID # 2004341 UFRGS
Secondary ID
Status Completed
Phase N/A
First received February 26, 2009
Last updated February 26, 2009
Start date December 2005
Est. completion date August 2007

Study information

Verified date February 2009
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

The objective of this study was to analyze changes in cardiac function using Doppler echocardiogram in critical patients during weaning from mechanical ventilation using two different weaning methods (pressure support and T-tube) and to compare a subgroup of patients: success vs. failure in weaning and patients with vs. without heart disease.


Description:

Weaning from mechanical ventilation (MV) involves physiological changes that can overload the cardiorespiratory system due to changes in the interaction between patient and ventilator.

This was a randomized crossover clinical trial that included patients in an intensive care unit (ICU) who had been on MV for more than 48 hours and who were considered ready for weaning. Cardiorespiratory variables, oxygenation, electrocardiogram (ECG) and Doppler echocardiogram findings were analyzed at baseline and after 30 minutes in each trial weaning method (PSV and T-tube). Comparisons were made between PSV and T-tube, weaning success and failure and patients with and without heart disease, using ANOVA and Student's t test. The level of significance was set at p < 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients hemodynamically stable

- conscious (Glasgow scale = 13)

- with adequate gaseous exchange (O2 saturation = 95%, fraction of inspired oxygen (FiO2) = 40% and positive end-expiratory pressure (PEEP) = 5

- with no acidosis or alkalosis)

- normal electrolyte levels

- presence of respiratory drive

- informed consent was signed by the patients and/or family members

Exclusion Criteria:

- hemodynamic instability

- severe intracranial disease

- barotrauma

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Federal University of Rio Grande do Sul Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

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