Passive Leg Raising - an Important Diagnostic Manoeuvre

NCT03454802 — Not applicable, Completed, 11 participants, Region MidtJylland Denmark

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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

Registry	NCT03454802, acronym PLR-ANS
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, sequential, masking: single, basic science
Enrollment	11 (Actual)
Sponsor	Region MidtJylland Denmark (Other); collaborators: Edwards Lifesciences
Conditions	Cardiovascular Insufficiency
Interventions	Passive Leg Raising (Diagnostic test)
Dates	start 2018-09-01, primary completion 2020-10-01, completion 2020-10-01, first posted 2018-03-06, last updated 2021-09-24
Locations	1 site in Denmark

-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.

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+Detailed description

See above

+Arms and interventions

Arm	Type	Interventions	Description
Normal subjects	Active comparator	Diagnostic Test: Passive Leg Raising	Normal subjects 'Passive Leg Raising'
ICU patients	Active comparator	Diagnostic Test: Passive Leg Raising	ICU patients 'Passive Leg Raising'
Cardiac Outpatients	Active comparator	Diagnostic Test: Passive Leg Raising	Cardiac Outpatients 'Passive Leg Raising'

Passive Leg Raising (Diagnostic test): See above

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

Consenting after written and oral information

Exclusion Criteria:

Contraindications to PLR: intracranial or abdominal hypertension

+Locations (1)

Facility	City	Country	Status
Regionshospitalet Silkeborg	Silkeborg, Central Jutland	Denmark

+Publications

Results publication: 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. PMID 16540963

+Investigators

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

My Notes

Public

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