Clinical trial NCT05297318: HPI in Older Patients Undergoing Major Gastrointestinal Surgery
Official title: Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Severity and Duration of Intraoperative Hypotension
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time-weighted average mean arterial pressure less than 65 mmHg
timeFrame: preoperative and postoperative 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chih-Jun Lai
state: Zhongzheng
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Jun Lai, MD
role: PRINCIPAL_INVESTIGATOR
References: