HPI in Older Patients Undergoing Major Gastrointestinal Surgery
Primary Purpose
the Severity and Duration of Intraoperative Hypotension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hypotension prediction index guided
without hypotesion prediction index guided
Sponsored by
About this trial
This is an interventional prevention trial for the Severity and Duration of Intraoperative Hypotension
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
hypotension prediction index guided
without hypotesion prediction index guided
Arm Description
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.
Patients will receive usual care during the operation without hypotension prediction index alerted.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05297318
First Posted
March 17, 2022
Last Updated
March 25, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05297318
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 28, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Severity and Duration of Intraoperative Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
patients and care providers did not know the whether the hypotension prediction index use during the operation.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypotension prediction index guided
Arm Type
Experimental
Arm Description
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.
Arm Title
without hypotesion prediction index guided
Arm Type
Sham Comparator
Arm Description
Patients will receive usual care during the operation without hypotension prediction index alerted.
Intervention Type
Device
Intervention Name(s)
hypotension prediction index guided
Intervention Description
patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension
Intervention Type
Other
Intervention Name(s)
without hypotesion prediction index guided
Intervention Description
patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care
Primary Outcome Measure Information:
Title
Time-weighted average mean arterial pressure less than 65 mmHg
Description
A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension
Time Frame
preoperative and postoperative 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Jun Lai, MD
Phone
0223123456
Ext
62158
Email
littlecherrytw@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo-Liong Chien, PD
Phone
33668017
Email
klchien@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
ethical issue: patients' privacy
Learn more about this trial
HPI in Older Patients Undergoing Major Gastrointestinal Surgery
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