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OpenTrials
Completed

NCT Number: NCT03454802

Passive Leg Raising - an Important Diagnostic Manoeuvre

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.

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Key information

Conditions

Cardiovascular Insufficiency

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionshospitalet Silkeborg

Silkeborg, Central Jutland, 8600, Denmark

About this study

See above

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Consenting after written and oral information

Exclusion criteria

Contraindications to PLR: intracranial or abdominal hypertension

Treatment and study plan

Passive Leg Raising

Diagnostic Test

See above

Primary outcomes

  1. Changes in cardiovascular variables I

    Time frame: 10 minutes

    stroke volume, SV (mL)

  2. Changes in cardiovascular variables II

    Time frame: 10 minutes

    pulse rate, PR (min^-1)

  3. Changes in cardiovascular variables III

    Time frame: 10 minutes

    blood pressure, BP (mmHg)

  4. Changes in cardiovascular variables IV

    Time frame: 10 minutes

    pulse oximetric saturation, SpO2 (%)

  5. 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)

  6. 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)

  7. Changes in HRV frequency domain variables VII

    Time frame: 10 minutes

    HRV relative power (absolute power/total power)

  8. Changes in HRV frequency domain variables VIII

    Time frame: 10 minutes

    HRV normalized power (%, normalized units, n.u.)

  9. Changes in HRV frequency domain variables IX

    Time frame: 10 minutes

    HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.

Sponsors and collaborators

Lead sponsor

Region MidtJylland Denmark

Other

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Acronym: PLR-ANS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2018
Registry last updated
Sep 24, 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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