Intraoperative HypotensionHPINCT03610165
Hypotension Prediction Index for Blood Pressure Management
A study testing Acumen HPI-enabled EV1000 screen in people with Intraoperative Hypotension, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Acumen HPI-enabled EV1000 screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥45 years
- ASA Physical Status 3 or 4
- Moderate- or high-risk surgery (for example, orthopedic, spine, urology, and general surgery)
- Planned invasive blood pressure monitoring
- General anesthesia
- Surgery duration expected to last >2 hours
- Planned overnight hospitalization
Who cannot join
- Contraindication to the invasive blood pressure monitoring
- Pregnancy
- Emergency surgery
- Known clinically important intracardiac shunts
- Known aortic stenosis with valve area ≤ 1.5 cm2
- Known moderate to severe aortic regurgitation
Show all 15Show fewer
- Known moderate to severe mitral regurgitation
- Known moderate to severe mitral stenosis
- Patient or surgical procedure type known as an SVV limitation16 (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6)
- Current persistent atrial fibrillation
- Congestive heart failure with ejection fraction <35%
- Neurosurgery
- Emergent or cardiovascular surgical procedure
- Patient who is confirmed to be pregnant
- Refusal of patient or authorized representative to sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Acumen Hypotension Prediction Index Software in Hypotension Management During Moderate to High-Risk Noncardiac Surgery: A Pilot Randomized Control Trial
Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity.
Aim: To determine whether use of Acumen HPI software guidance to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.
Primary hypothesis: Our primary hypothesis is that adding Acumen HPI software guidance to the information provided by the invasive arterial pressure monitoring during moderate- to high-risk noncardiac surgery reduces time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg.
Read the detailed description
STUDY RATIONALE Even when clinicians try to prevent intraoperative hypotension, they often fail because it is difficult to predict which patients will become hypotensive, much less when. A risk score for predicting minute-by-minute intraoperative hypotension is not currently available. Yet it seems likely that ability to identify when a patient is likely to become hypotensive, and the pathophysiology of the event, will improve hemodynamic management and perhaps patient outcome. Acumen HPI appears to be a reliable predictor of intraoperative hypotension, and should thus help clinicians anticipate and avoid hypotension. Furthermore, the secondary guidance provided by the Acumen HPI may help clinicians optimally manage fluids and thus prevent future episodes in the same patient.
AIMS To determine whether use of Acumen HPI software to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.
PRIMARY HYPOTHESIS Our primary hypothesis is that use of the Acumen HPI software guidance reduces TWA intraoperative hypotension below a threshold of 65 mmHg.
Specifically, we will compare the amount of intraoperative hypotension below mean-arterial pressure (MAP) threshold of 65 mmHg, in patients randomized to invasive arterial pressure monitoring vs. invasive arterial pressure monitoring with Acumen Hypotension Prediction Index software. In both cases, clinicians will strive to keep MAP above 65 mmHg to the extent practical.
- Conditions
- Intraoperative Hypotension
- Being tested
- Acumen HPI-enabled EV1000 screen, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen HPI-enabled EV1000 screenDevice
Acumen HPI-enabled EV1000 screen.
ControlDevice
Arterial waveform and pressures
| Study group | Role | What they receive |
|---|---|---|
| Arterial line - Control | Placebo comparator | Arterial line waveform and pressure Receives: Device: Control |
| Acumen HPI-enabled EV1000 screen | Experimental | Arterial line waveform and pressure + HPI alert from EV1000 monitor Receives: Device: Acumen HPI-enabled EV1000 screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.
MAP stands for mean arterial pressure. Time-weighted average MAP below 65 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Hypotension Severity (AUC-MAP) Under a Threshold of 65.
MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 65 mmHg and ended when MAP was greater than 65 mmHg; Hypotension severity (AUC-MAP) below the threshold of 65 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .
Duration of MAP Under a Threshold of 65 mmHg.
MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 65 mmHg
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Secondary outcomes (6)
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case
MAP stands for mean arterial pressure. Time-weighted average MAP below 60 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case
MAP stands for mean arterial pressure. Time-weighted average MAP below 55 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.
MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 60 mmHg and ended when MAP was greater than 60 mmHg.
Hypotension severity (AUC-MAP) below the threshold of 60 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.
MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 55 mmHg and ended when MAP was greater than 55 mmHg.
Hypotension severity (AUC-MAP) below the threshold of 55 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Duration of MAP Under a Threshold of 60 mmHg.
MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 60 mmHg
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Duration of MAP Under a Threshold of 55 mmHg.
MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 55 mmHg.
Measured: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start12 Jul 2018
- Primary completion1 Jun 2019
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Maheshwari, MD MPH, The Cleveland Clinic
- Investigators
- Kamal Maheshwari, MD, MPH, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610165
- Sponsor's protocol ID
- 18-557
- Acronym
- HPI
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Maheshwari K, Shimada T, Fang J, Ince I, Mascha EJ, Turan A, Kurz A, Sessler DI. Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial. Trials. 2019 May 3;20(1):255. doi: 10.1186/s13063-019-3329-0.
PubMed 31053082
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Acumen Hypotension Prediction Index Software in Hypotension Management During Moderate to High-Risk Noncardiac Surgery: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03610165
- Acronym / sponsor ID
- HPI / 18-557
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity.
Aim: To determine whether use of Acumen HPI software guidance to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.
Primary hypothesis: Our primary hypothesis is that adding Acumen HPI software guidance to the information provided by the invasive arterial pressure monitoring during moderate- to high-risk noncardiac surgery reduces time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg.
Detailed description
STUDY RATIONALE Even when clinicians try to prevent intraoperative hypotension, they often fail because it is difficult to predict which patients will become hypotensive, much less when. A risk score for predicting minute-by-minute intraoperative hypotension is not currently available. Yet it seems likely that ability to identify when a patient is likely to become hypotensive, and the pathophysiology of the event, will improve hemodynamic management and perhaps patient outcome. Acumen HPI appears to be a reliable predictor of intraoperative hypotension, and should thus help clinicians anticipate and avoid hypotension. Furthermore, the secondary guidance provided by the Acumen HPI may help clinicians optimally manage fluids and thus prevent future episodes in the same patient.
AIMS To determine whether use of Acumen HPI software to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.
PRIMARY HYPOTHESIS Our primary hypothesis is that use of the Acumen HPI software guidance reduces TWA intraoperative hypotension below a threshold of 65 mmHg.
Specifically, we will compare the amount of intraoperative hypotension below mean-arterial pressure (MAP) threshold of 65 mmHg, in patients randomized to invasive arterial pressure monitoring vs. invasive arterial pressure monitoring with Acumen Hypotension Prediction Index software. In both cases, clinicians will strive to keep MAP above 65 mmHg to the extent practical.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity.
| Arm | Type | Receives |
|---|---|---|
| Arterial line - Control | Placebo comparator | Device: ControlArterial line waveform and pressure |
| Acumen HPI-enabled EV1000 screen | Experimental | Device: Acumen HPI-enabled EV1000 screenArterial line waveform and pressure + HPI alert from EV1000 monitor |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Age ≥45 years
- ASA Physical Status 3 or 4
- Moderate- or high-risk surgery (for example, orthopedic, spine, urology, and general surgery)
- Planned invasive blood pressure monitoring
Key exclusion criteria (15 listed)
- Contraindication to the invasive blood pressure monitoring
- Pregnancy
- Emergency surgery
- Known clinically important intracardiac shunts
- Known aortic stenosis with valve area ≤ 1.5 cm2
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 |
|---|---|---|
| Acumen HPI-enabled EV1000 screenAcumen HPI-enabled EV1000 screen. | Device | Acumen HPI-enabled EV1000 screen |
| ControlArterial waveform and pressures | Device | Arterial line - Control |
Primary outcome
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
MAP stands for mean arterial pressure. Time-weighted average MAP below 65 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Hypotension Severity (AUC-MAP) Under a Threshold of 65.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .
MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 65 mmHg and ended when MAP was greater than 65 mmHg; Hypotension severity (AUC-MAP) below the threshold of 65 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Duration of MAP Under a Threshold of 65 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 65 mmHg
6 secondary outcomes
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Duration of MAP Under a Threshold of 60 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Duration of MAP Under a Threshold of 55 mmHg.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31053082Maheshwari K, Shimada T, Fang J, Ince I, Mascha EJ, Turan A, Kurz A, Sessler DI. Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial. Trials. 2019 May 3;20(1):255. doi: 10.1186/s13063-019-3329-0.
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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.
Kamal Maheshwari, MD, MPH study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen HPI-enabled EV1000 screen in people with Intraoperative Hypotension, run by The Cleveland Clinic 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 8 inclusion and 15 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 19 May 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg. (time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03610165, which also lists 1 linked publication.
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 19 May 2021.