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Passive Leg Raising - an Important Diagnostic Manoeuvre

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03454802
Acronym
PLR-ANS
Enrollment
11
Registered
2018-03-06
Start date
2018-09-01
Completion date
2020-10-01
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Insufficiency

Brief 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.

Detailed description

See above

Interventions

DIAGNOSTIC_TESTPassive Leg Raising

See above

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Region MidtJylland Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Consenting after written and oral information

Exclusion criteria

Contraindications to PLR: intracranial or abdominal hypertension

Design outcomes

Primary

MeasureTime frameDescription
Changes in cardiovascular variables I10 minutesstroke volume, SV (mL)
Changes in cardiovascular variables II10 minutespulse rate, PR (min\^-1)
Changes in cardiovascular variables III10 minutesblood pressure, BP (mmHg)
Changes in cardiovascular variables IV10 minutespulse oximetric saturation, SpO2 (%)
Changes in HRV frequency domain variables V10 minutesHeart 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 VI10 minutesHRV 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 VII10 minutesHRV relative power (absolute power/total power)
Changes in HRV frequency domain variables VIII10 minutesHRV normalized power (%, normalized units, n.u.)
Changes in HRV frequency domain variables IX10 minutesHRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026