Ability of Hypotension Prediction Index to Predict Hypotension Events in Thoracic Surgery

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05117151
• Collaborator: (none)
• Enrollment: 30
• Anticipated Duration (Months): 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Perioperative/Postoperative Complications	Diagnostic Test: hypotension prediction index

Detailed Description

Hypotension prediction index is a novel introduced monitoring-tool that aims to predict hypotension events before their occurence, and has been reported to have superior predictive ability than the commonly measured perioperative hemodynamic variables. To date, there is no information regarding its ability to predict hypotension events in each phase of thoracic surgery.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ability of Hypotension Prediction Index to Predict Future Hypotension Events in Each Phase of Thoracic Surgery: an Observational Pilot Study
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; monitor intraoperative hypotension prediction index as well as hemodynamic variables to exam the ability in predicting hypotension events of each variable

Outcome Measures

Primary Outcome Measures

1. ability of hypotension prediction index in predicting hypotension events [3 hours]

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

Secondary Outcome Measures

1. ability of dynamic parameters in predicting hypotension events [3 hours]

   to calculate the sensitivity/specificity and AUROC of dynamic parameters in predicting hypotension events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• adults undergoing scheduled VATS surgery

Exclusion Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Study Chair: Chun-Yu Wu, Ph.D., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05117151
• Other Study ID Numbers: 202109061RIND
• First Posted: Nov 11, 2021
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension; Postoperative Complications

Study Results

No Results Posted as of Jan 12, 2022