Hypotension Prediction Index for Blood Pressure Management

NCT03610165 | Completed Results FDA Device

• 1 other identifier: 18-557
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (6)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

Arterial line - Control

PLACEBO COMPARATOR

Arterial line waveform and pressure

Device: Control

Acumen HPI-enabled EV1000 screen

EXPERIMENTAL

Arterial line waveform and pressure + HPI alert from EV1000 monitor

Device: Acumen HPI-enabled EV1000 screen

Interventions

Acumen HPI-enabled EV1000 screen DEVICE

Acumen HPI-enabled EV1000 screen.

Acumen HPI-enabled EV1000 screen

Control DEVICE

Arterial waveform and pressures

Arterial line - Control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 31053082 DERIVED

Results Point of Contact

• Title: Dr. Kamal Maheshwari
• Organization: Cleveland Clinic Foundation

maheshk@ccf.org

216-4454311

Study Officials

• Kamal Maheshwari, MD, MPH

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 1, 2018
• Study Start: July 12, 2018
• Primary Completion: June 1, 2019
• Study Completion: March 31, 2021
• Last Updated: May 19, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-04

Locations

US (1)