Passive Leg Raise During Cardiopulmonary Resuscitation

Sponsor

Lazarski University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03617978

Collaborator

Wroclaw Medical University (Other)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

108

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Elevation Hemodynamic Instability Cardiopulmonary Resuscitation	Procedure: Hemodynamics parameters	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Masking Description:

participants will not be able to see the device measuring the hemodynamic parameters

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Cardiac output - CO [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

Secondary Outcome Measures

Stroke Volume - SV [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
thoracic fluid content - TFC [during procedure]
It is an indicator of total fluid volume, both intracellular and extracellular. The parameter is measured using ICON device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy participants
voluntary informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Lazarski University	Warsaw	Masovian	Poland	02-662

Sponsors and Collaborators

Lazarski University
Wroclaw Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Łukasz Szarpak, Associate Professor, Lazarski University

ClinicalTrials.gov Identifier:

NCT03617978

Other Study ID Numbers:

PLR_2018_UL

First Posted:

Aug 7, 2018

Last Update Posted:

Aug 7, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Łukasz Szarpak, Associate Professor, Lazarski University

cardiopulmonary resuscitation

hemodynamic

medical simulation

leg elevation

Study Results

No Results Posted as of Aug 7, 2018