Passive Leg Raising - an Important Diagnostic Manoeuvre

NCT ID: NCT03454802

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-10-01

Brief Summary

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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

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See above

Conditions

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Cardiovascular Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Normal subjects

Normal subjects 'Passive Leg Raising'

Group Type ACTIVE_COMPARATOR

Passive Leg Raising

Intervention Type DIAGNOSTIC_TEST

See above

ICU patients

ICU patients 'Passive Leg Raising'

Group Type ACTIVE_COMPARATOR

Passive Leg Raising

Intervention Type DIAGNOSTIC_TEST

See above

Cardiac Outpatients

Cardiac Outpatients 'Passive Leg Raising'

Group Type ACTIVE_COMPARATOR

Passive Leg Raising

Intervention Type DIAGNOSTIC_TEST

See above

Interventions

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Passive Leg Raising

See above

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Consenting after written and oral information

Exclusion Criteria

Contraindications to PLR: intracranial or abdominal hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

Region MidtJylland Denmark

OTHER

Sponsor Role lead

Responsible Party

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Soren Sondergaard

Senior Consultant, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Toft, MD

Role: STUDY_CHAIR

Head of Centre of Planned Surgery, Silkeborg Regional Hospital

Locations

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Regionshospitalet Silkeborg

Silkeborg, Central Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 16540963 (View on PubMed)

Other Identifiers

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619909

Identifier Type: -

Identifier Source: org_study_id

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