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OpenTrials
Completed

NCT Number: NCT05147012

Intraoperative Hypotension Predicted by Mean Arterial Pressure

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital

Bron, 69500, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. AUC ROC of LepMAP

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Intraoperative Hypotension Predicted by Observation of Mean Arterial Pressure : a Retrospective Cohort Preliminary Study

Acronym: HYPPOPOPAM

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 7, 2021
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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