HYPPOPOPAM: Intraoperative Hypotension Predicted by Mean Arterial Pressure

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT05147012
Collaborator
(none)
80
1
13
6.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Data collected

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Intraoperative Hypotension Predicted by Observation of Mean Arterial Pressure : a Retrospective Cohort Preliminary Study
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
control group

focus group

Other: Data collected
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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Exclusion Criteria:
  • complex hemodynamic cases (heart, lung and liver transplantation)

  • using extracorporeal membrane oxygenation.

  • Patient who object to take part of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05147012
Other Study ID Numbers:
  • HYPPOPOPAM_2020
First Posted:
Dec 7, 2021
Last Update Posted:
Dec 7, 2021
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2021