CClinicalTrials.gg
CompletedNCT05147012HYPPOPOPAMUpdated Dec 7, 2021

Intraoperative Hypotension Predicted by Mean Arterial Pressure

An observational study in Wedge Resection and Lobectomy by Video-thoracoscopies, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-07.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Wedge Resection
  • Lobectomy by Video-thoracoscopies

Browse trials for

Keywords

  • wedge resection
  • lobectomy
  • video-thoracoscopies
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 80 is close to the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • complex hemodynamic cases (heart, lung and liver transplantation)
  • using extracorporeal membrane oxygenation.
  • Patient who object to take part of the study.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • control group
  • focus group

    Other: Data collected

Interventions

  • OtherData 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.

06

What researchers measure

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

    Time frame: Only during perioperative period

07

Study locations

1 site
  • Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital
    Bron, 69500, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05147012
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Dec 7, 2021
Start date
Mar 1, 2019
Primary completion
Mar 1, 2019
Completion
Mar 31, 2020
Last update
Dec 7, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion