Disorders of the Autonomic Nervous SystemNCT00844935
Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients
An observational study of Disorders of the Autonomic Nervous System and Cardiovascular Abnormalities, run by University of California, San Francisco at 1 site in United States.
Trial summary
This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities, Respiratory Disorders
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- 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: Mechanically ventilated patients in intensive care
Who may be able to join
- Receiving mechanical ventilation in medical-surgical intensive care unit;
- Eighteen years of age or older;
- Expectation of receiving initial spontaneous breathing trial within the next 24 hours.
Who cannot join
- Pregnant;
- Expectation of non-survival when ventilator is discontinued;
- Cardiac rhythm of atrial fibrillation;
- Paced cardiac rhythm.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Medical Center
San Francisco, California, 94122
About this study
Official title: The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care
This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV.
Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure;
Read more
Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay;
Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.
- Conditions
- Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities, Respiratory Disorders
- Keywords
- Heart rate variability, mechanical ventilation, weaning,, spontaneous breathing trial
- Medical subject headings
- Autonomic Nervous System Diseases, Cardiovascular Abnormalities, Respiration Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of the Autonomic Nervous SystemStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational model
- Cohort
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Drew, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844935
- Sponsor's protocol ID
- H6052-33761-01
- Status last verified
- Mar 2012
- First submitted
- 13 Feb 2009
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Electrocardiographic Autonomic Nervous System Function Measures for Predicting Cardiopulmonary Recovery of Mechanically Ventilated Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT00844935
- Acronym / sponsor ID
- H6052-33761-01
- Conditions
- Disorders of the Autonomic Nervous System, Cardiovascular Abnormalities, Respiratory Disorders
- Keywords
- Heart rate variability, mechanical ventilation, weaning,, spontaneous breathing trial
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 16 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.
This research proposal has two main objectives. The first is to increase understanding of the underlying physiological interactions that occur between the cardiovascular, pulmonary, and ANS during transition between positive pressure mechanical ventilation (MV) and spontaneous breathing. The second is to determine if heart rate variability, (HRV) a reflection of autonomic nervous system (ANS) activity, and autonomic information flow (AIF), a set of nonlinear measures derived from HRV, both measured in the intensive care unit (ICU) can predict patient outcomes including successful weaning and in-hospital recovery time after an episode of cardiopulmonary compromise requiring MV.
Hypothesis 1. Transitions between mechanically supported ventilation and spontaneous breathing will disturb cardiovascular synchrony, altering the relationship of HRV, AIF, respiratory rate, and blood pressure;
Hypothesis 2. More normal HRV and AIF values, measured during baseline MV and sedation awakening (a period immediately prior to SBT when sedative medications are discontinued) will be associated with easier weaning, and shorter intensive care unit (ICU) and hospital lengths of stay; more abnormal measurements will be associated with longer lengths of stay;
Hypothesis 3. AIF is a more sensitive predictor of successful weaning from MV than HRV.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients in intensive care
Key inclusion criteria (3 listed)
- Receiving mechanical ventilation in medical-surgical intensive care unit;
- Eighteen years of age or older;
- Expectation of receiving initial spontaneous breathing trial within the next 24 hours.
Key exclusion criteria (4 listed)
- Pregnant;
- Expectation of non-survival when ventilator is discontinued;
- Cardiac rhythm of atrial fibrillation;
- Paced cardiac rhythm.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
Related trials for Disorders of the Autonomic Nervous System
Active, not recruitingPhase 2
Safety and Efficacy of the PAINLESS Nerve Growth Factor CHF6467 in Optic Pathway Glioma (OPG)
Optic Pathway Glioma
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Recruiting
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Supine Hypertension, Autonomic Failure
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.
Barbara Drew, PhD principal investigator
University of California, San Francisco
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 Disorders of the Autonomic Nervous System and Cardiovascular Abnormalities, run by University of California, San Francisco at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Mar 2012. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 28 Mar 2012.