Intraoperative Hypotension
Conditions
Brief 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.
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.
Interventions
Acumen HPI-enabled EV1000 screen.
DEVICEControl
Arterial waveform and pressures
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time- Weighted Average (TWA) 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). | 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. | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension Severity (AUC-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). | 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. |
| Hypotension Severity (AUC-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). | 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. |
| Duration of 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). | MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 55 mmHg. |
| Duration of 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). | 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-weighted Average MAP Below a Threshold of 60 mmHg Per Case | 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 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-weighted Average MAP Below a Threshold of 55 mmHg Per Case | 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 55 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements. |
Countries
United States
Participant flow
Pre-assignment details
214 met inclusion criteria and were randomized to treatment. One patient was excluded from analysis due to non-availability of data from technical issues.
Participants by arm
| Arm | Count |
|---|---|
| Arterial Line - Control Arterial line waveform and pressure
Control: Arterial waveform and pressures | 108 |
| 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. | 105 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device didn't work | 0 | 1 |
Baseline characteristics
| Characteristic | Arterial Line - Control | Acumen HPI-enabled EV1000 Screen | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 | 66 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 47 Participants | 90 Participants |
| Sex: Female, Male Male | 65 Participants | 58 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 105 |
| other Total, other adverse events | 0 / 108 | 0 / 105 |
| serious Total, serious adverse events | 0 / 108 | 0 / 105 |
Outcome results
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
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Duration of MAP Under a Threshold of 65 mmHg. | 9.3 min |
| Acumen HPI-enabled EV1000 Screen | Duration of MAP Under a Threshold of 65 mmHg. | 7.7 min |
p-value: 0.32895% CI: [-3.3, 1]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Hypotension Severity (AUC-MAP) Under a Threshold of 65. | 34.2 mmHg·min |
| Acumen HPI-enabled EV1000 Screen | Hypotension Severity (AUC-MAP) Under a Threshold of 65. | 32.7 mmHg·min |
p-value: 0.71595% CI: [-12, 7]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg. | 0.14 mmHg |
| Acumen HPI-enabled EV1000 Screen | Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg. | 0.14 mmHg |
p-value: 0.75795% CI: [-0.03, 0.04]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Duration of MAP Under a Threshold of 55 mmHg. | 0.17 min |
| Acumen HPI-enabled EV1000 Screen | Duration of MAP Under a Threshold of 55 mmHg. | 0.67 min |
p-value: 0.40395% CI: [0, 0]Wilcoxon (Mann-Whitney)
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
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Duration of MAP Under a Threshold of 60 mmHg. | 2.0 min |
| Acumen HPI-enabled EV1000 Screen | Duration of MAP Under a Threshold of 60 mmHg. | 2.0 min |
p-value: 0.88995% CI: [-0.67, 0.67]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg. | 0.17 mmHg·min |
| Acumen HPI-enabled EV1000 Screen | Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg. | 1.00 mmHg·min |
p-value: 0.30295% CI: [0, 0]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg. | 5.3 mmHg·min |
| Acumen HPI-enabled EV1000 Screen | Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg. | 6.0 mmHg·min |
p-value: 0.6195% CI: [-0.67, 2]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case | 0 mmHg |
| Acumen HPI-enabled EV1000 Screen | Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case | 0 mmHg |
p-value: 0.22695% CI: [0, 0]Wilcoxon (Mann-Whitney)
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.
Time frame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arterial Line - Control | Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case | 0.02 mmHg |
| Acumen HPI-enabled EV1000 Screen | Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case | 0.03 mmHg |
p-value: 0.37695% CI: [-0.001, 0.011]Wilcoxon (Mann-Whitney)