Passive Leg Raising - an Important Diagnostic Manoeuvre

Cardiovascular Insufficiency Clinical Trial

— PLR-ANS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454802
• Other study ID #: 619909
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2021
• Source: Region MidtJylland Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Consenting after written and oral information

Exclusion Criteria:

Contraindications to PLR: intracranial or abdominal hypertension

Related Conditions & MeSH terms

• Cardiovascular Insufficiency

Intervention

Diagnostic Test:
• Passive Leg Raising
See above

Locations

Country	Name	City	State
Denmark	Regionshospitalet Silkeborg	Silkeborg	Midtjylland

Sponsors (2)

Lead Sponsor	Collaborator
Region MidtJylland Denmark	Edwards Lifesciences

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cardiovascular variables I	stroke volume, SV (mL)	10 minutes
Primary	Changes in cardiovascular variables II	pulse rate, PR (min^-1)	10 minutes
Primary	Changes in cardiovascular variables III	blood pressure, BP (mmHg)	10 minutes
Primary	Changes in cardiovascular variables IV	pulse oximetric saturation, SpO2 (%)	10 minutes
Primary	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)	10 minutes
Primary	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)	10 minutes
Primary	Changes in HRV frequency domain variables VII	HRV relative power (absolute power/total power)	10 minutes
Primary	Changes in HRV frequency domain variables VIII	HRV normalized power (%, normalized units, n.u.)	10 minutes
Primary	Changes in HRV frequency domain variables IX	HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.	10 minutes