Hypotension Prediction Index in Major Gastrointestinal Surgery

Investigation of the Effect of Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension During Major Gastrointestinal Surgery: A Randomized Trial

Intraoperative hypotension (IOH) is defined as a mean arterial pressure (MAP) of < 65mmHg during surgery. Patients undergoing major gastrointestinal (GI) surgery, such as esophagectomy with reconstruction, are at a high-risk of IOH because such surgeries typically require more than 3h to complete and require blood transfusion or inotrope administration. Critically, these surgeries involve organ removal or substitute connection, which require wound or flap anastomosis. IOH is believed to be associated with postoperative anastomosis necrosis. It increases the risk of postoperative intrathoracic or abdominal infection, resulting in septic shock, postoperative major organ dysfunction and mortality.

The data of TWA-MAP< 65mmHg in the HPI guidance group will be significantly lower than that in the group without HPI guidance.

Study Overview

• Status: Completed
• Conditions: the Effect of Hypotension Prediction Index Application
• Intervention / Treatment: Device: hypotension prediction index guided; Device: without hypotesion prediction index guided

Detailed Description

Intraoperative hypotension (IOH) is defined as a mean arterial pressure (MAP) of < 65mmHg during surgery. Patients undergoing major gastrointestinal (GI) surgery, such as esophagectomy with reconstruction, are at a high-risk of IOH because such surgeries typically require more than 3h to complete and require blood transfusion or inotrope administration. Critically, these surgeries involve organ removal or substitute connection, which require wound or flap anastomosis. IOH is believed to be associated with postoperative anastomosis necrosis. It increases the risk of postoperative intrathoracic or abdominal infection, resulting in septic shock, postoperative major organ dysfunction and mortality.

The Hypotension Prediction Index (HPI) is an algorithm made commercially available in 2019. On the basis of arterial waveform features, HPI predicts hypotension defined as MAP < 65 mmHg for at least 1 min. In two previous randomized trials(RCTs), the primary outcome was the severity and duration of hypotension, defined as a time-weighted average mean arterial pressure (TWA-MAP) less than 65 mmHg (formula: (total area under MAP<65mmHg(mmHg*hours))/(surgery length (hours));normal range:0.01-0.5mmHg).A higher data of TWA-MAP<65mmHg indicates severe and longer IOH. However, according to the results of the previous two RCTs, the effects of HPI guidance during surgery remain inconclusive.

We aim to investigate whether HPI guidance can be used to reduce the duration and severity of hypotension during major GI surgery. Our hypothesis is that the data of TWA-MAP< 65mmHg in the HPI guidance group will be significantly lower than that in the group without HPI guidance. Postoperative major complications and mortality will be followed.

Methods: Sixty patients aged 20 to 80 years undergoing elective GI surgery will be randomized to receive hemodynamic management with or without HPI guidance. Clinicians caring for patients assigned to the HPI guidance group will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation. Primary outcome is the data of TWA-MAP<65mmHg. Postoperative complications will be recorded on postoperative day 3,7 and 30. The mortality rate from the time of hospitalization to postoperative 30 days will be recorded.

The data of TWA-MAP< 65mmHg in the HPI guidance group will be significantly lower than that in the group without HPI guidance.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng Dist.
    • Taipei, Zhongzheng Dist., Taiwan, 100
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients receiving elective major gastrointestinal surgery

Exclusion Criteria:

• emergent surgery
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients with hypotension prediction index guided; Patients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation.	Device: hypotension prediction index guided; patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension
Other: patients without hypotension prediction index gudied; Patients will receive usual care during the operation without hypotension prediction index alerted.	Device: without hypotesion prediction index guided; patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time-weighted average mean arterial pressure less than 65 mmHg	.A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension	during the operation

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Actual): January 27, 2022
• Study Completion (Actual): March 6, 2022

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 202105065RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: due to the ethical concern

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No