HPI in Laparoscopic Colorectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HPI guidance, No HPI guidance.
- Who it may be relevant to
- Registry conditions: the Duration and Severity of Intraoperative Hypotension. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Hypotension Prediction Index for Prevention of Hypotension and Postoperative Complications During Laparoscopic Surgery for Colorectal Cancer: A Multi-Center Randomized Trial
Overview
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.
Interventions
- Device HPI guidance
patients with HPI guidance - Device No HPI guidance
patients without HPI guidance
Primary outcome measures
- time weighted average mean arterial pressure (TWA MAP) <65 mmHg (unit: mmHg) [Time frame: during the whole surgery]
Eligibility criteria
Inclusion criteria
- patients undergoing elective laparoscopic colorectal surgery
Exclusion criteria
- Severe heart or lung diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- National Taiwan University Hospital and Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT06756672 · 202408037DINB