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Clinical Trials/NCT03454802
NCT03454802
Completed
Not Applicable

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

Region MidtJylland Denmark1 site in 1 country11 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Insufficiency
Sponsor
Region MidtJylland Denmark
Enrollment
11
Locations
1
Primary Endpoint
Changes in HRV frequency domain variables V
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
October 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Region MidtJylland Denmark
Responsible Party
Principal Investigator
Principal Investigator

Soren Sondergaard

Senior Consultant, MD, PhD

Region MidtJylland Denmark

Eligibility Criteria

Inclusion Criteria

  • Consenting after written and oral information

Exclusion Criteria

  • Contraindications to PLR: intracranial or abdominal hypertension

Outcomes

Primary Outcomes

Changes in HRV frequency domain variables V

Time Frame: 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

Time Frame: 10 minutes

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

Changes in cardiovascular variables I

Time Frame: 10 minutes

stroke volume, SV (mL)

Changes in cardiovascular variables III

Time Frame: 10 minutes

blood pressure, BP (mmHg)

Changes in cardiovascular variables II

Time Frame: 10 minutes

pulse rate, PR (min\^-1)

Changes in HRV frequency domain variables VII

Time Frame: 10 minutes

HRV relative power (absolute power/total power)

Changes in HRV frequency domain variables IX

Time Frame: 10 minutes

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

Changes in cardiovascular variables IV

Time Frame: 10 minutes

pulse oximetric saturation, SpO2 (%)

Changes in HRV frequency domain variables VI

Time Frame: 10 minutes

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

Study Sites (1)

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