HPI in Older Patients Undergoing Major Gastrointestinal Surgery

NCT05297318 | Completed

• 1 other identifier: 202112225DIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

the Severity and Duration of Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

hypotension prediction index guided

EXPERIMENTAL

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

without hypotesion prediction index guided

SHAM COMPARATOR

Patients will receive usual care during the operation without hypotension prediction index alerted.

Other: without hypotesion prediction index guided

Interventions

hypotension prediction index guided DEVICE

patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension

hypotension prediction index guided

without hypotesion prediction index guided OTHER

patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care

without hypotesion prediction index guided

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Chih-Jun Lai

Taipei, Zhongzheng, 100225, Taiwan

Location

Study Officials

• Chih-Jun Lai, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: patients and care providers did not know the whether the hypotension prediction index use during the operation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: March 28, 2022
• Primary Completion: October 2, 2023
• Study Completion: November 5, 2023
• Last Updated: November 21, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)