HPI in Older Patients Undergoing Major Gastrointestinal Surgery

Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial

The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.

Study Overview

• Status: Completed
• Conditions: the Severity and Duration of Intraoperative Hypotension
• Intervention / Treatment: Device: hypotension prediction index guided; Other: without hypotesion prediction index guided

Detailed Description

Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)<65mmHg).

Objectives: to investigate whether HPI could prevent the intraoperative hypotension happened.

Patients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.

Expected result: The HPI would significantly decrease the intraoperative hypotension incidence.

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

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng
    • Taipei, Zhongzheng, Taiwan, 100225
      • Chih-Jun Lai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• the age of patients>=65 years old
• patients receivedd major gastrointestinal surgery

Exclusion Criteria:

• patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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
Sham Comparator: without hypotesion prediction index guided; Patients will receive usual care during the operation without hypotension prediction index alerted.	Other: 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	preoperative and postoperative 30 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chih-Jun Lai, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): November 5, 2023

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 202112225DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: ethical issue: patients' privacy

Drug and device information, study documents

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