IndividualityPHERVRNCT02761031
Perioperative Heart Rate Variability Analysis in Realtime
An observational study of Individuality and Perioperative/Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Individuality, Perioperative/Postoperative Complications, Heart Rate and Rhythm Disorders
- How many people
- 88 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2016to Aug 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients between the ages of 18 and 80 who are undergoing non-cardiac surgery under general anesthesia at Vienna General Hospital may participate.
Who may be able to join
- Patients undergoing non-cardiac surgery under general anesthesia
- Patients aged 18-80 years
- Patients who are capable of giving informed consent
Who cannot join
- Patients <18 or >80 years of age
- Patients with an active cardiac pace maker
- Patients with an absent sinus rhythm in ECG
- Patients presenting with a preexisting arrhythmia
- Patients requiring postoperative ICU therapy
- Patients with pheochromocytoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Heart Rate Variability Analysis in Realtime: Detection of Cardiovascular and Autonomic Dysfunction
This study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.
- Conditions
- Individuality, Perioperative/Postoperative Complications, Heart Rate and Rhythm Disorders, Surgical Complications From General Anesthesia
- Keywords
- Heart rate variability, Electrocardiography, Observational study, Non-interventional study, Risk assessment, Perioperative
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
The analysis of heart rate variability (HRV) has been used to assess autonomic nervous system responses to therapeutic interventions, and to quantify risk in a wide variety of both cardiac and non-cardiac disorders when combined with other diagnostic tests - though HRV analysis has seen its greatest cardiologic use in post-myocardial infarction risk stratification and in assessing risk for arrhythmic events. HRV analysis has become widespread and relatively simple to perform - however, until now, these analyses have not been performed in detail in the perioperative period.
Measured: During and immediately subsequent to surgery performed under general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndividualityStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Vienna University of Technology
- Responsible party
- Principal investigator, Adam Joel Bukaty, Medical University of Vienna
- Investigators
- Adam J Bukaty, MD, Principal investigator, Medical University of ViennaUlrich Klein, MD, PD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761031
- Sponsor's protocol ID
- 2095/2015
- Acronym
- PHERVR
- Status last verified
- Aug 2018
- First submitted
- 2 May 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Heart Rate Variability Analysis in Realtime: Detection of Cardiovascular and Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT02761031
- Acronym / sponsor ID
- PHERVR / 2095/2015
- Conditions
- Individuality, Perioperative/Postoperative Complications, Heart Rate and Rhythm Disorders, Surgical Complications From General Anesthesia
- Keywords
- Heart rate variability, Electrocardiography, Observational study, Non-interventional study, Risk assessment, Perioperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Vienna University of Technology
- Study start
- Apr 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 4 May 2016 (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 study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. Through retrospective analysis of patients' heart rate variability (HRV), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients between the ages of 18 and 80 who are undergoing non-cardiac surgery under general anesthesia at Vienna General Hospital may participate.
Key inclusion criteria (3 listed)
- Patients undergoing non-cardiac surgery under general anesthesia
- Patients aged 18-80 years
- Patients who are capable of giving informed consent
Key exclusion criteria (6 listed)
- Patients <18 or >80 years of age
- Patients with an active cardiac pace maker
- Patients with an absent sinus rhythm in ECG
- Patients presenting with a preexisting arrhythmia
- Patients requiring postoperative ICU therapy
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
Time frame: During and immediately subsequent to surgery performed under general anesthesia
The analysis of heart rate variability (HRV) has been used to assess autonomic nervous system responses to therapeutic interventions, and to quantify risk in a wide variety of both cardiac and non-cardiac disorders when combined with other diagnostic tests - though HRV analysis has seen its greatest cardiologic use in post-myocardial infarction risk stratification and in assessing risk for arrhythmic events. HRV analysis has become widespread and relatively simple to perform - however, until now, these analyses have not been performed in detail in the perioperative period.
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 20 Aug 2018.
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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.
Adam J Bukaty, MD principal investigator
Medical University of Vienna
Ulrich Klein, MD, PD study director
Medical University of Vienna
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 Individuality and Perioperative/Postoperative Complications, run by Medical University of Vienna at 1 site in Austria.
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 6 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 20 Aug 2018. 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 Austria. 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 (time frame: During and immediately subsequent to surgery performed under general anesthesia). 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 20 Aug 2018.