HPI in Older Patients Undergoing Major Gastrointestinal Surgery

Not Applicable

Completed

• Conditions: the Severity and Duration of Intraoperative Hypotension

• Registration Number: NCT05297318
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-25
• Study Start: 2022-03-28
• Study First Posted: 2022-03-28
• Primary Completion: 2023-10-02
• Study Completion: 2023-11-05
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time-weighted average mean arterial pressure less than 65 mmHg	preoperative and postoperative 30 days	A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension

Trial Locations

Locations (1)

Chih-Jun Lai; 🇨🇳 Taipei, Zhongzheng, Taiwan