HPI in Laparoscopic Colorectal Surgery

NCT ID: NCT06756672

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2031-12-31

Brief Summary

Using the Hypotension Prediction Index in patients undergoing laparoscopic colorectal surgery, including data from National Taiwan University Hospital and Taipei Veterans General Hospital

Detailed Description

Intraoperative hypotension is a common occurrence during laparoscopic colorectal cancer resection, often attributable to factors such as general anesthesia, the growing population of elderly patients, and the use of pneumoperitoneum during surgery. This condition, defined as a mean arterial pressure (MAP) below 65 mmHg, is linked to major organ complications within 30 days postoperatively. Introduced in 2019, the Hypotension Prediction Index (HPI) is an algorithm designed to predict the onset of intraoperative hypotension. Previous studies have used the time-weighted average MAP below 65 mmHg as a primary endpoint, calculated as the area under the MAP curve <65 mmHg (mmHg × hours) divided by the duration of surgery (hours), with a value ≥0 indicating severity. Higher values reflect more severe hypotension. However, research on the application of HPI in laparoscopic colorectal cancer resection remains limited. This study aims to determine whether the use of HPI can reduce the severity of intraoperative hypotension in patients undergoing laparoscopic colorectal cancer resection and whether it can decrease the incidence of major postoperative organ complications. A total of 120 patients, aged 20-80 years and undergoing elective laparoscopic colorectal cancer resection, will be randomly assigned to two groups: an intervention group guided by HPI and a control group without HPI guidance. In the intervention group, an alert will be triggered when the HPI exceeds 85, indicating a potential MAP drop below 65 mmHg, whereas the control group will initiate hypotension treatment only when MAP falls below 65 mmHg. Both groups will adhere to the same intraoperative hypotension management protocols, including fluid resuscitation, vasopressor administration, and observation. The primary treatment outcome will be the time-weighted average MAP <65 mmHg, and major postoperative organ complications will be monitored for 30 days post-surgery.

Conditions

the Duration and Severity of Intraoperative Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HPI guidance

patients with HPI guidance

Group Type: EXPERIMENTAL

HPI guidance

Intervention Type: DEVICE

patients with HPI guidance

patients in the control group

patients without HPI guidance

Group Type: ACTIVE_COMPARATOR

No HPI guidance

Intervention Type: DEVICE

patients without HPI guidance

Interventions

HPI guidance

patients with HPI guidance

Intervention Type: DEVICE

No HPI guidance

patients without HPI guidance

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients undergoing elective laparoscopic colorectal surgery

Exclusion Criteria

• Severe heart or lung diseases

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital and Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Jun Lai, MD, PhD

Role: CONTACT

littlecherrytw@gmail.com

+886-965327939

Chien-Kun Ting, MD, PhD

Role: CONTACT

ckting2@gmail.com

Facility Contacts

Chih-Jun Lai, MD, PhD

Role: primary

littlecherrytw@gmail.com

Chien-Kun Ting, MD, PhD

Role: backup

ckting2@gmail.com

Other Identifiers

202408037DINB

Identifier Type: -

Identifier Source: org_study_id