NCT05698433

Brief Summary

Objective: The aim of this study was to use machine learning to predict and interpret intraoperative high blood pressure variability（IHBPV）. Design: Retrospective cohort study. Setting: Beijing Tsinghua Chang Gung Hospital . Data resources: 47520 operations performed under general anesthesia in the central operating room from March 2016 to April 2022. Interventions: None. Measurements: investigators collected data on preoperative baseline information and intraoperative variables. The model was constructed with python and run using the following models: XGBoost, random forest, LGBoost, and logistic regression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47,520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

January 16, 2023

Last Update Submit

June 20, 2023

Conditions

Blood Pressure Immeasurable

Keywords

Blood PressurePerioperative

Outcome Measures

Primary Outcomes (1)

  • Intraoperative High Blood Pressure Variability

    we define cases of IHBPV as situations where the CV of MAP exceeds 20% during the surgery, regardless of whether the increase in blood pressure variability is due to a decrease or an increase in blood pressure.

    Perioperative period

Study Arms (1)

high Blood pressure variability team

The group with excessive blood pressure fluctuation during operation is high Blood pressure variability team

Other: No intervention

Interventions

No interventionOTHER

No intervention

high Blood pressure variability team

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

he original database consisted of 52250 cases of general anesthesia surgery. The sample size was based on the scale of the existing database, of which 47520 surgeries met the criteria of this study.

You may qualify if:

  • patients who received general anesthesia, intravenous anesthesia, or intravenous-inhalation anesthesia, and ASA1-5 grade.

You may not qualify if:

  • surgeries with missing key information and surgeries that were not monitored for blood pressure throughout the operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhifeng Gao

Beijing, Beijing Municipality, 102218, China

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

January 2, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)