Critical CareNCT00851825
Heart Rate Variability During Weaning From Mechanical Ventilation
An observational study of Critical Care and Weaning, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Weaning
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2003to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- arterial hypotension (systolic blood pressure < 100mmHg), severe brain disease, barotraumas, presence of thoracic drain or tracheostomy, using vasoactive and sedative drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Care, Weaning
- Keywords
- autonomic modulation, heart rate, pressure support ventilation, T-tube, Mechanical ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability analysis
Measured: minutes
Secondary outcomes (1)
Cardiorespiratory variables
Measured: minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMar 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Silvia R Veira, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851825
- Sponsor's protocol ID
- 03-435
- Status last verified
- May 2009
- First submitted
- 25 Feb 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of T-Tube and Pressure Support on Cardiorespiratory Variables and Heart Rate Variability During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00851825
- Acronym / sponsor ID
- 03-435
- Conditions
- Critical Care, Weaning
- Keywords
- autonomic modulation, heart rate, pressure support ventilation, T-tube, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- arterial hypotension (systolic blood pressure < 100mmHg), severe brain disease, barotraumas, presence of thoracic drain or tracheostomy, using vasoactive and sedative drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
heart rate variability analysis
Time frame: minutes
1 secondary outcome
Cardiorespiratory variables
Time frame: minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia R Veira, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Weaning, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability analysis (time frame: minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2009.