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CompletedNCT03610165HPIUpdated May 19, 2021Results posted

Hypotension Prediction Index for Blood Pressure Management

An interventional study of Acumen HPI-enabled EV1000 screen and Control in Intraoperative Hypotension, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-05-19.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Intraoperative Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 214 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
214 participants (actual)

Study arms

  • Placebo comparator
    Arterial line - Control

    Arterial line waveform and pressure

    Device: Control

  • Experimental
    Acumen HPI-enabled EV1000 screen

    Arterial line waveform and pressure + HPI alert from EV1000 monitor

    Device: Acumen HPI-enabled EV1000 screen

Interventions

  • DeviceAcumen HPI-enabled EV1000 screen

    Acumen HPI-enabled EV1000 screen.

  • DeviceControl

    Arterial waveform and pressures

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  2. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .

  3. 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

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

Secondary outcomes

  1. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  2. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  3. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  4. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  5. 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

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

  6. 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.

    Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

07

Results

Posted Feb 5, 2021

Participant flow

Participant flow — Overall Study
MilestoneArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Started108106
Completed108105
Not completed01
Withdrew: Device didn't work01

Outcome measures

PrimaryTime- 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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · mmHg
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.
mmHgArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.0.14 (0.03 to 0.39)0.14 (0.03 to 0.37)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.757 · Median difference (final values): 0 · 95% CI -0.03 to 0.04
PrimaryHypotension 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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .
Reported as:
Median · mmHg·min
Hypotension Severity (AUC-MAP) Under a Threshold of 65.
mmHg·minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Hypotension Severity (AUC-MAP) Under a Threshold of 65.34.2 (8.5 to 112.7)32.7 (6.3 to 102.0)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.715 · Median difference (final values): -1.3 · 95% CI -12 to 7
PrimaryDuration 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

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · min
Duration of MAP Under a Threshold of 65 mmHg.
minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Duration of MAP Under a Threshold of 65 mmHg.9.3 (2.3 to 23.5)7.7 (2.0 to 18.3)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.328 · Median difference (final values): -1 · 95% CI -3.3 to 1
SecondaryTime-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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · mmHg
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case
mmHgArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case0.02 (0.00 to 0.11)0.03 (0.00 to 0.13)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.376 · Median difference (final values): 0 · 95% CI -0.001 to 0.011
SecondaryTime-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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · mmHg
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case
mmHgArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case0 (0 to 0.03)0 (0 to 0.04)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.226 · Median difference (final values): 0 · 95% CI 0 to 0
SecondaryHypotension 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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · mmHg·min
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.
mmHg·minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.5.3 (0.00 to 29.2)6.0 (0.33 to 28.3)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.610 · Median difference (final values): 0 · 95% CI -0.67 to 2.00
SecondaryHypotension 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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · mmHg·min
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.
mmHg·minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.0.17 (0 to 6.7)1.00 (0 to 7.7)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.302 · Median difference (final values): 0 · 95% CI 0 to 0
SecondaryDuration 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

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · min
Duration of MAP Under a Threshold of 60 mmHg.
minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Duration of MAP Under a Threshold of 60 mmHg.2.0 (0.00 to 7.7)2.0 (0.33 to 7.3)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.889 · Median difference (final values): 0 · 95% CI -0.67 to 0.67
SecondaryDuration 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.

Time frame:
MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Reported as:
Median · min
Duration of MAP Under a Threshold of 55 mmHg.
minArterial Line - ControlAcumen HPI-enabled EV1000 Screen
Duration of MAP Under a Threshold of 55 mmHg.0.17 (0 to 1.7)0.67 (0 to 2.3)
Statistical analysis
  • Arterial Line - Control vs Acumen HPI-enabled EV1000 Screen · Wilcoxon (Mann-Whitney) · p = 0.403 · Median difference (final values): 0 · 95% CI 0 to 0

Adverse events

Collected over During the hospital stay. The median length of hospital stay of both groups is 6 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arterial Line - Control0/108 (0%)0/108 (0%)0/108 (0%)
Acumen HPI-enabled EV1000 Screen0/105 (0%)0/105 (0%)0/105 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arterial Line - ControlAcumen HPI-enabled EV1000 ScreenTotal
Mean66 ± 1067 ± 1066 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Arterial Line - ControlAcumen HPI-enabled EV1000 ScreenTotal
Female434790
Male6558123
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Arterial Line - ControlAcumen HPI-enabled EV1000 ScreenTotal
Count of participants——0
08

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
09

References and documents

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 documents

  • Protocol and statistical analysis plan · Sep 13, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03610165
Lead sponsor
The Cleveland Clinic
Responsible party
Kamal Maheshwari, MD MPH (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
Aug 1, 2018
Start date
Jul 12, 2018
Primary completion
Jun 1, 2019
Completion
Mar 31, 2021
Results posted
Feb 5, 2021
Last update
May 19, 2021

Study contacts

Kamal Maheshwari, MD, MPH
study director · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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