Heart Rate DeterminationNCT03267017
Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability
An observational study of Heart Rate Determination, run by Rambam Health Care Campus.
Trial summary
This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Rate Determination
- What is being tested?
- posture changes
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 May 2019
- 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: Study patients
Who may be able to join
- Age 18-80
- Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring
Who cannot join
- Heart Rate other than sinus
- Cardiac Pacemaker Status
- Transplanted Heart
About this study
Official title: Correlation Between Respiratory Variability of R-R Intervals and in Invasive Systolic Blood Pressure During Changes in Posture and Positive End Expiratory Pressure
This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus
- Conditions
- Heart Rate Determination
- Being tested
- posture changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posture changesOther
Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| Patient scheduled for surgery under general anesthesia | Not described Receives: Other: posture changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure
Measured: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate DeterminationStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267017
- Sponsor's protocol ID
- RRV PPV
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Respiratory Variability of R-R Intervals and in Invasive Systolic Blood Pressure During Changes in Posture and Positive End Expiratory Pressure
- ClinicalTrials.gov ID
- NCT03267017
- Acronym / sponsor ID
- RRV PPV
- Conditions
- Heart Rate Determination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 30 Aug 2017 (actual)
- 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 prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient scheduled for surgery under general anesthesia | – | Other: posture changes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study patients
Key inclusion criteria (2 listed)
- Age 18-80
- Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring
Key exclusion criteria (3 listed)
- Heart Rate other than sinus
- Cardiac Pacemaker Status
- Transplanted Heart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| posture changesFollowing induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O | Other | Patient scheduled for surgery under general anesthesia |
Primary outcome
Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure
Time frame: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rate Determination, run by Rambam Health Care Campus.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure (time frame: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later). 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 30 Aug 2017.