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Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT00852891
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Description
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Brief 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.

Condition or disease
Critical Care Weaning

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.

Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Time Perspective: Prospective
Official Title: Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation: a Randomized Crossover Clinical Trial
Study Start Date : December 2005
Actual Study Completion Date : August 2007
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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
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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
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Brazil
Federal University of Rio Grande do Sul
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Silvia RR Vieira, PhD Hospital de Clínicas de Porto Alegre
More Information
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Responsible Party: Silvia Regina Rios Vieira, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00852891    
Other Study ID Numbers: 2004341 UFRGS
First Posted: February 27, 2009    Key Record Dates
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