Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension

September 21, 2022 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).

During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are scheduled for spine surgery and need positional change from supine to prone positioin.

Description

Inclusion Criteria:

  • Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia

Exclusion Criteria:

  • arrythmia
  • pulmonary disease
  • increased intracranial pressure
  • decreased cardiac function (ejection fraction < 50%)
  • obesity (body mass index > 40)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-hypotensive
Mean blood pressure is maintained after positional change from supine to prone.
Other: Positional change from supine to prone
Patient is turned from supine to prone position for spine surgery
Hypotensive
Mean blood pressure decrease < 20% after positional change from supine to prone.
Other: Positional change from supine to prone
Patient is turned from supine to prone position for spine surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic arterial elastance before positional change
Time Frame: 1 minute before positional change
Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change
1 minute before positional change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBSMC 2021-04-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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