Passive Leg Raise During Cardiopulmonary Resuscitation

August 6, 2018 updated by: Łukasz Szarpak, Lazarski University

Impact of Passive Leg Raise on Hemodynamic Effect: A Randomized Crossover Experimental Study

during cardiopulmonary resuscitation, an important element of the procedure is to achieve optimal organ perfusion. For this purpose, high quality chest compressions is one of the basic elements of the procedure. however, similarly as in the case of hypovolemic shock, elevation of the lower limbs may be helpful. The study is a randomized cross-over study and includes the effect of lower limb elevation on hemodynamic parameters in healthy participants.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian
      • Warsaw, Masovian, Poland, 02-662
        • Recruiting
        • Faculty of Medicine, Lazarski University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy participants
  • voluntary informed consent

Exclusion Criteria:

  • hip injury during the six months preceding the examination
  • back pain
  • kidney damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: None Elevation
Participant placed on a flat surface. Study participant connected to the measuring hemodynamic parameters device
Procedure: Hemodynamics parameters
real-time evaluation of cardiac output parameters using the ICON device
EXPERIMENTAL: Elevation angle of 20 degrees
Participant placed on a flat surface, lower limbs raised and supported at an angle of 20 degrees. Study participant connected to the measuring hemodynamic parameters device
Procedure: Hemodynamics parameters
real-time evaluation of cardiac output parameters using the ICON device
EXPERIMENTAL: Elevation angle of 30 degrees
Participant placed on a flat surface, lower limbs raised and supported at an angle of 30 degrees. Study participant connected to the measuring hemodynamic parameters device
Procedure: Hemodynamics parameters
real-time evaluation of cardiac output parameters using the ICON device
EXPERIMENTAL: Elevation angle of 45 degrees
Participant placed on a flat surface, lower limbs raised and supported at an angle of 45 degrees. Study participant connected to the measuring hemodynamic parameters device
Procedure: Hemodynamics parameters
real-time evaluation of cardiac output parameters using the ICON device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output - CO
Time Frame: during procedure
the volume of blood that the heart pumps into blood vessels in one minute. It is the product of the frequency of heart contractions (HR) and stroke volume (SV). The parameter is measured using ICON device
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Volume - SV
Time Frame: during procedure
the amount of blood pressed through one of the heart chambers into the appropriate arterial reservoir during a single heart contraction. The parameter is measured using ICON device
during procedure
thoracic fluid content - TFC
Time Frame: during procedure
It is an indicator of total fluid volume, both intracellular and extracellular. The parameter is measured using ICON device
during procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lazarski University

Collaborators

Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (ACTUAL)

August 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLR_2018_UL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be available at the main author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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