Intraoperative Hypotension Predicted by Mean Arterial Pressure

NCT05147012 | Completed

• 1 other identifier: HYPPOPOPAM_2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Wedge Resection; Lobectomy by Video-thoracoscopies

Keywords

wedge resection; lobectomy; video-thoracoscopies

Outcome Measures

Primary Outcomes (1)

• AUC ROC of LepMAP

  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

  Only during perioperative period

Study Arms (2)

control group

focus group

Other: Data collected

Interventions

Data collected OTHER

The variable of the characteristic of the patients (i.e.: age, sex, hypertension, diabetes, atrial fibrillation, coronary arteries diseases, body mass index (BMI), surgery, medications) were retrieved from the anesthesia consultation file (Easily, Hospices Civiles de Lyon, France). We retrieved the mean arterial pressure from our local anesthesia software for each patient ( Diane®, Bow medical, Amiens France). We also performed an automatic extraction of data from our anesthesia software (Diane, Bow Medical, France) with a rate of 1 value / minute for some continuous arterial pressure. All data was extracted from our institutional database and collected by a physician who was not involved in the care of the study patients.

focus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all gender minimum age : 18 years old Healthy volunteers are not accepted

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital

Bron, 69500, France

Location

MeSH Terms

Interventions

Routinely Collected Health Data

Intervention Hierarchy (Ancestors)

Health Care Surveys; Health Services Research; Health Planning; Health Care Economics and Organizations; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: December 7, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2020
• Last Updated: December 7, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)