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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial line - Control | Placebo Comparator | Arterial line waveform and pressure |
|
| Acumen HPI-enabled EV1000 screen | Experimental | Arterial line waveform and pressure + HPI alert from EV1000 monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acumen HPI-enabled EV1000 screen | Device | Acumen HPI-enabled EV1000 screen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Maheshwari, MD, MPH | The Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31053082 | Derived | 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. |
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214 met inclusion criteria and were randomized to treatment. One patient was excluded from analysis due to non-availability of data from technical issues.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arterial Line - Control | Arterial line waveform and pressure Control: Arterial waveform and pressures |
| FG001 | Acumen HPI-enabled EV1000 Screen | Arterial line waveform and pressure + HPI alert from EV1000 monitor Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arterial Line - Control | Arterial line waveform and pressure Control: Arterial waveform and pressures |
| BG001 | Acumen HPI-enabled EV1000 Screen | Arterial line waveform and pressure + HPI alert from EV1000 monitor Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | mmHg | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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During the hospital stay. The median length of hospital stay of both groups is 6 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arterial Line - Control | Arterial line waveform and pressure Control: Arterial waveform and pressures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kamal Maheshwari | Cleveland Clinic Foundation | 216-4454311 | maheshk@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2018 | Dec 15, 2020 | Prot_SAP_000.pdf |
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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.
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| Control | Device | Arterial waveform and pressures |
|
| 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. | 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. | 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. | 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 | 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. | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | mmHg·min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) . |
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| Primary | 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 | Posted | Median | Inter-Quartile Range | min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | mmHg | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | mmHg | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | mmHg·min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | mmHg·min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | min | MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery). |
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| 0 |
| 108 |
| 0 |
| 108 |
| 0 |
| 108 |
| EG001 | Acumen HPI-enabled EV1000 Screen | Arterial line waveform and pressure + HPI alert from EV1000 monitor Acumen HPI-enabled EV1000 screen: Acumen HPI-enabled EV1000 screen. | 0 | 105 | 0 | 105 | 0 | 105 |
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