NCT05117151

Brief Summary

Investigators design this prospective observational study to exam the ability of hypotension prediction index in predicting intraoperative hypotension events in each phase of thoracic surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

October 31, 2021

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • ability of hypotension prediction index in predicting hypotension events

    to calculate the sensitivity/specificity and AUROC of hypotension prediction index in predicting hypotension events

    3 hours

Secondary Outcomes (1)

  • ability of dynamic parameters in predicting hypotension events

    3 hours

Study Arms (1)

Observation

monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable

Diagnostic Test: hypotension prediction index

Interventions

monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable

Observation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults undergoing scheduled VATS surgery

You may qualify if:

  • adults undergoing scheduled VATS surgery

You may not qualify if:

  • pregnant women
  • patients in intensive care units
  • patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
  • patients with ongoing infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

  • Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.

    PMID: 26083768BACKGROUND
  • Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

    PMID: 29894315BACKGROUND
  • Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.

    PMID: 32065827BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chun-Yu Wu, Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 11, 2021

Study Start

March 23, 2022

Primary Completion

August 2, 2023

Study Completion

August 2, 2023

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations