HPI in Older Patients Undergoing Major Gastrointestinal Surgery

Not Applicable

Completed

• Conditions: the Severity and Duration of Intraoperative Hypotension
• Interventions: Device: hypotension prediction index guided; Other: without hypotesion prediction index guided

• 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypotension prediction index guided	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.
without hypotesion prediction index guided	without hypotesion prediction index guided	Patients will receive usual care during the operation without hypotension prediction index alerted.

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