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Clinical Trials/NCT05297318
NCT05297318CompletedNot Applicable

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

National Taiwan University Hospital2 sites in 1 country60 target enrollmentStarted: March 28, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Time-weighted average mean arterial pressure less than 65 mmHg

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Masking Description

patients and care providers did not know the whether the hypotension prediction index use during the operation.

Eligibility Criteria

Ages
65 Years to 80 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Time-weighted average mean arterial pressure less than 65 mmHg

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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