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CompletedNCT03454802PLR-ANSUpdated Sep 24, 2021

Passive Leg Raising - an Important Diagnostic Manoeuvre

An interventional study of Passive Leg Raising in Cardiovascular Insufficiency, sponsored by Region MidtJylland Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Region MidtJylland Denmark · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

See above

02

Conditions studied

  • Cardiovascular Insufficiency
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Consenting after written and oral information

Exclusion criteria

Exclusion Criteria:

Contraindications to PLR: intracranial or abdominal hypertension

04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Normal subjects

    Normal subjects 'Passive Leg Raising'

    Diagnostic Test: Passive Leg Raising

  • Active comparator
    ICU patients

    ICU patients 'Passive Leg Raising'

    Diagnostic Test: Passive Leg Raising

  • Active comparator
    Cardiac Outpatients

    Cardiac Outpatients 'Passive Leg Raising'

    Diagnostic Test: Passive Leg Raising

Interventions

  • Diagnostic testPassive Leg Raising

    See above

05

What researchers measure

Primary outcomes

  1. Changes in cardiovascular variables I

    stroke volume, SV (mL)

    Time frame: 10 minutes

  2. Changes in cardiovascular variables II

    pulse rate, PR (min\^-1)

    Time frame: 10 minutes

  3. Changes in cardiovascular variables III

    blood pressure, BP (mmHg)

    Time frame: 10 minutes

  4. Changes in cardiovascular variables IV

    pulse oximetric saturation, SpO2 (%)

    Time frame: 10 minutes

  5. Changes in HRV frequency domain variables V

    Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)

    Time frame: 10 minutes

  6. Changes in HRV frequency domain variables VI

    HRV absolute power (ms\^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)

    Time frame: 10 minutes

  7. Changes in HRV frequency domain variables VII

    HRV relative power (absolute power/total power)

    Time frame: 10 minutes

  8. Changes in HRV frequency domain variables VIII

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

    Time frame: 10 minutes

  9. Changes in HRV frequency domain variables IX

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

    Time frame: 10 minutes

06

Study locations

1 site
  • Regionshospitalet Silkeborg
    Silkeborg, Midtjylland 8600, Denmark
07

References and documents

Publications

  • Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06. PubMed 16540963 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03454802
Lead sponsor
Region MidtJylland Denmark
Collaborators
Edwards Lifesciences
Responsible party
Soren Sondergaard (Senior Consultant, MD, PhD, Region MidtJylland Denmark) — Principal investigator
First posted
Mar 6, 2018
Start date
Sep 1, 2018
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Sep 24, 2021

Study contacts

Peter Toft, MD
study chair · Head of Centre of Planned Surgery, Silkeborg Regional Hospital

Oversight

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

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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