Hypotension Prediction Index in Major Gastrointestinal Surgery

NCT04966364 | Completed DMC

• 1 other identifier: 202105065RINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative hypotension (IOH) is defined as a mean arterial pressure (MAP) of \< 65mmHg during surgery. Patients undergoing major gastrointestinal (GI) surgery, such as esophagectomy with reconstruction, are at a high-risk of IOH because such surgeries typically require more than 3h to complete and require blood transfusion or inotrope administration. Critically, these surgeries involve organ removal or substitute connection, which require wound or flap anastomosis. IOH is believed to be associated with postoperative anastomosis necrosis. It increases the risk of postoperative intrathoracic or abdominal infection, resulting in septic shock, postoperative major organ dysfunction and mortality. The data of TWA-MAP\< 65mmHg in the HPI guidance group will be significantly lower than that in the group without HPI guidance.

Conditions

the Effect of Hypotension Prediction Index Application

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

  during the operation

Study Arms (2)

patients with hypotension prediction index guided

ACTIVE COMPARATOR

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

patients without hypotension prediction index gudied

OTHER

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

Device: 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

patients with hypotension prediction index guided

without hypotesion prediction index guided DEVICE

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

patients without hypotension prediction index gudied

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients receiving elective major gastrointestinal surgery

You may not qualify if:

• emergent surgery
• pregnant women

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100, Taiwan

Location

Related Publications (1)

• Lai CJ, Cheng YJ, Han YY, Hsiao PN, Lin PL, Chiu CT, Lee JM, Tien YW, Chien KL. Hypotension prediction index for prevention of intraoperative hypotension in patients undergoing general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2024 Jun 15;13(1):57. doi: 10.1186/s13741-024-00414-7.

  PMID: 38879506 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participants and care provider and outcome assessor are blinded
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: using hypotension prediction index guided in the operation

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 19, 2021
• Study Start: July 22, 2021
• Primary Completion: January 27, 2022
• Study Completion: March 6, 2022
• Last Updated: July 25, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)