- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851825
Heart Rate Variability During Weaning From Mechanical Ventilation
May 7, 2009 updated by: Hospital de Clinicas de Porto Alegre
The Effect of T-Tube and Pressure Support on Cardiorespiratory Variables and Heart Rate Variability During Weaning From Mechanical Ventilation
The discontinuation of mechanical ventilation (MV) and the recovery of spontaneous breathing can lead to important cardiovascular alterations due to changes in the intrathoracic pressure.
The autonomic modulation assessed through heart rate variability (HRV) during weaning from MV and its impact on cardiorespiratory variables has not been well elucidated yet.
To evaluate the effect of T-tube (TT) and pressure support ventilation (PSV) during weaning from MV on cardiorespiratory variables and heart rate variability.
Study Overview
Status
Completed
Conditions
Detailed Description
Thirty patients who had received MV for ≥ 48 hours and who met the criteria for weaning were assessed.
Two different weaning methods were used and randomization was performed to choose one of the following sequences (baseline, PSV, rest, TT; or baseline, TT, rest, PSV).
HRV was assessed by heart rate spectral analysis during MV, PSV, and TT.
Each intervention lasted 30 minutes and there was a 30-minute rest period between the interventions.
At the end of each period of time, the following cardiorespiratory variables were analyzed: respiratory rate (f), minute ventilation (VE), tidal volume (VT), rapid shallow breathing index (f/VT), peripheral oxygen saturation (SpO2), heart rate (HR) and blood pressure.
In the HRV, the total spectral power (TP), the low frequency (LF) and the high frequency (HF) components, and the ratio between the low/high frequency (LF/HF) components were calculated.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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RS
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Porto Alegre, RS, Brazil
- Federal University of Rio Grande do Sul
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with respiratory failure receiving MV for more than 48 hours, who had been admitted to the Intensive Care Unit (ICU) of the Hospital de Clínicas de Porto Alegre, and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in this study.
Description
Inclusion Criteria:
- Patients with respiratory failure receiving MV for more than 48 hours
- for weaning from MV according to the parameters previously defined were selected to participate in this study
Exclusion Criteria:
- arterial hypotension (systolic blood pressure < 100mmHg), severe brain disease, barotraumas, presence of thoracic drain or tracheostomy, using vasoactive and sedative drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
heart rate variability analysis
Time Frame: minutes
|
minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiorespiratory variables
Time Frame: minutes
|
minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Silvia R Veira, PhD, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
February 25, 2009
First Submitted That Met QC Criteria
February 25, 2009
First Posted (Estimate)
February 26, 2009
Study Record Updates
Last Update Posted (Estimate)
May 8, 2009
Last Update Submitted That Met QC Criteria
May 7, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 03-435
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.