Passive Leg Raising - an Important Diagnostic Manoeuvre (PLR-ANS)

September 18, 2021 updated by: Soren Sondergaard, Region MidtJylland Denmark

Passive Leg Raising - an Important Diagnostic Manoeuvre and Its Dependency on the Activity of the Autonomous Nervous System in Critically Ill Patients and Healthy Subjects

The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre.

The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU.

Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

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

  • Denmark
    • Midtjylland
      • Silkeborg, Midtjylland, Denmark, 8600
        • Regionshospitalet Silkeborg

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Consenting after written and oral information

Exclusion Criteria:

Contraindications to PLR: intracranial or abdominal hypertension

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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Normal subjects
Normal subjects 'Passive Leg Raising'
Diagnostic test: Passive Leg Raising
See above
ACTIVE_COMPARATOR: ICU patients
ICU patients 'Passive Leg Raising'
Diagnostic test: Passive Leg Raising
See above
ACTIVE_COMPARATOR: Cardiac Outpatients
Cardiac Outpatients 'Passive Leg Raising'
Diagnostic test: Passive Leg Raising
See above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cardiovascular variables I
Time Frame: 10 minutes
stroke volume, SV (mL)
10 minutes
Changes in cardiovascular variables II
Time Frame: 10 minutes
pulse rate, PR (min^-1)
10 minutes
Changes in cardiovascular variables III
Time Frame: 10 minutes
blood pressure, BP (mmHg)
10 minutes
Changes in cardiovascular variables IV
Time Frame: 10 minutes
pulse oximetric saturation, SpO2 (%)
10 minutes
Changes in HRV frequency domain variables V
Time Frame: 10 minutes
Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)
10 minutes
Changes in HRV frequency domain variables VI
Time Frame: 10 minutes
HRV absolute power (ms^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)
10 minutes
Changes in HRV frequency domain variables VII
Time Frame: 10 minutes
HRV relative power (absolute power/total power)
10 minutes
Changes in HRV frequency domain variables VIII
Time Frame: 10 minutes
HRV normalized power (%, normalized units, n.u.)
10 minutes
Changes in HRV frequency domain variables IX
Time Frame: 10 minutes
HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.
10 minutes

Collaborators and Investigators

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

Sponsor

Region MidtJylland Denmark

Collaborators

Edwards Lifesciences

Investigators

  • Study Chair: Peter Toft, MD, Head of Centre of Planned Surgery, Silkeborg Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2018

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (ACTUAL)

March 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 619909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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