Passive Leg Raising - an Important Diagnostic Manoeuvre

Not Applicable

Completed

• Conditions: Cardiovascular Insufficiency
• Interventions: Diagnostic Test: Passive Leg Raising

• Registration Number: NCT03454802
• Lead Sponsor: Region MidtJylland Denmark

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

Study Timeline

• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-06
• Study Start: 2018-09-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Consenting after written and oral information

Exclusion Criteria

Contraindications to PLR: intracranial or abdominal hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Normal subjects	Passive Leg Raising	Normal subjects 'Passive Leg Raising'
ICU patients	Passive Leg Raising	ICU patients 'Passive Leg Raising'
Cardiac Outpatients	Passive Leg Raising	Cardiac Outpatients 'Passive Leg Raising'

Primary Outcome Measures

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

Trial Locations

Locations (1)

Regionshospitalet Silkeborg; 🇩🇰 Silkeborg, Midtjylland, Denmark