NCT03617978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

August 1, 2018

Last Update Submit

August 6, 2018

Conditions

Keywords

cardiopulmonary resuscitationhemodynamicmedical simulationleg elevation

Outcome Measures

Primary Outcomes (1)

  • Cardiac output - CO

    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 Outcomes (2)

  • Stroke Volume - SV

    during procedure

  • thoracic fluid content - TFC

    during procedure

Study Arms (4)

None Elevation

EXPERIMENTAL

Participant placed on a flat surface. Study participant connected to the measuring hemodynamic parameters device

Procedure: Hemodynamics parameters

Elevation angle of 20 degrees

EXPERIMENTAL

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

Elevation angle of 30 degrees

EXPERIMENTAL

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

Elevation angle of 45 degrees

EXPERIMENTAL

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

Interventions

real-time evaluation of cardiac output parameters using the ICON device

Elevation angle of 20 degreesElevation angle of 30 degreesElevation angle of 45 degreesNone Elevation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy participants
  • voluntary informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Lazarski University

Warsaw, Masovian Voivodeship, 02-662, Poland

RECRUITING

Central Study Contacts

Lukasz Szarpak, PhD

CONTACT

Jacek Smereka, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will not be able to see the device measuring the hemodynamic parameters
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 7, 2018

Study Start

August 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations