Intraoperative Hypotension Predicted by Mean Arterial Pressure

Wedge Resection Clinical Trial

— HYPPOPOPAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05147012
• Other study ID #: HYPPOPOPAM_2020
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2020
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Wedge Resection

Intervention

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.

Locations

Country	Name	City	State
France	Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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