Intraoperative Hypotension Predicted by Mean Arterial Pressure

Completed

• Conditions: Wedge Resection; Lobectomy by Video-thoracoscopies
• Interventions: Other: Data collected

• Registration Number: NCT05147012
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Hypothesis : the area under the ROC curves (ROC Area Under Curves) at 1, 2 and 5 minutes of LepMAP would be superior to ΔMAP

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2020-03-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2021-12-06
• Last Update Submitted: 2021-12-06
• Study First Posted: 2021-12-07
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All lobectomy including for another study (VATOFA study) with continuous invasive blood pressure monitoring per arterial line
• All pancreaticoduodenectomy or hepatectomy including for another study (CARBODAV study) with continuous invasive blood pressure monitoring per arterial line
• age 18 or over

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Exclusion Criteria

• complex hemodynamic cases (heart, lung and liver transplantation)
• using extracorporeal membrane oxygenation.
• Patient who object to take part of the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
focus group	Data collected	-

Primary Outcome Measures

Name	Time	Method
AUC ROC of LepMAP	Only during perioperative period	The primary outcome measure is the AUC ROC of LepMAP 1, 2 and 5 minute before hypotension to predict hypotension defined as a mean arterial pressure less tha 65 mmHg

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital; 🇫🇷 Bron, France