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Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852891
First Posted: February 27, 2009
Last Update Posted: February 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition
Critical Care Weaning

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation: a Randomized Crossover Clinical Trial

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Enrollment: 24
Study Start Date: December 2005
Study Completion Date: August 2007
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving MV for more than 48 hours, who had been admitted to the Intensive Care Unit (ICU), and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in this study.
Criteria

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
  Contacts and Locations
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): NCT00852891


Locations
Brazil
Federal University of Rio Grande do Sul
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Silvia RR Vieira, PhD Hospital de Clínicas de Porto Alegre
  More Information

Responsible Party: Silvia Regina Rios Vieira, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00852891     History of Changes
Other Study ID Numbers: 2004341 UFRGS
First Submitted: February 26, 2009
First Posted: February 27, 2009
Last Update Posted: February 27, 2009
Last Verified: February 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
weaning
echocardiogram
diastolic dysfunction
Mechanical ventilation