Leg ElevationNCT03617978
Passive Leg Raise During Cardiopulmonary Resuscitation
A study testing Hemodynamics parameters in people with Leg Elevation and Hemodynamic Instability, run by Lazarski University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leg Elevation, Hemodynamic Instability, Cardiopulmonary Resuscitation
- What is being tested?
- Hemodynamics parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2018to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy participants
- voluntary informed consent
Who cannot join
- hip injury during the six months preceding the examination
- back pain
- kidney damage
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Lazarski University
Warsaw, Masovian Voivodeship, 02-662
Lukasz Szarpak, 500186225, lukasz.szarpak@gmail.com
About this study
Official title: 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.
- Being tested
- Hemodynamics parameters
- Keywords
- cardiopulmonary resuscitation, hemodynamic, medical simulation, leg elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamics parametersProcedure or surgery
real-time evaluation of cardiac output parameters using the ICON device
| Study group | Role | What they receive |
|---|---|---|
| None Elevation | Experimental | Participant placed on a flat surface. Study participant connected to the measuring hemodynamic parameters device Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Hemodynamics parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during procedure
Secondary outcomes (2)
Stroke Volume - SV
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
Measured: during procedure
thoracic fluid content - TFC
It is an indicator of total fluid volume, both intracellular and extracellular. The parameter is measured using ICON device
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Aug 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg ElevationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617978
- Sponsor's protocol ID
- PLR_2018_UL
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available at the main author
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Passive Leg Raise on Hemodynamic Effect: A Randomized Crossover Experimental Study
- ClinicalTrials.gov ID
- NCT03617978
- Acronym / sponsor ID
- PLR_2018_UL
- Keywords
- cardiopulmonary resuscitation, hemodynamic, medical simulation, leg elevation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| None Elevation | Experimental | Procedure: Hemodynamics parametersParticipant placed on a flat surface. Study participant connected to the measuring hemodynamic parameters device |
| Elevation angle of 20 degrees | Experimental | Procedure: Hemodynamics parametersParticipant 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 |
| Elevation angle of 30 degrees | Experimental | Procedure: Hemodynamics parametersParticipant 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 |
| Elevation angle of 45 degrees | Experimental | Procedure: Hemodynamics parametersParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy participants
- voluntary informed consent
Key exclusion criteria (3 listed)
- hip injury during the six months preceding the examination
- back pain
- kidney damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamics parametersreal-time evaluation of cardiac output parameters using the ICON device | Procedure or surgery | Elevation angle of 20 degrees, Elevation angle of 30 degrees, Elevation angle of 45 degrees, None Elevation |
Primary outcome
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
2 secondary outcomes
Stroke Volume - SV
Time frame: during procedure
thoracic fluid content - TFC
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided. Data will be available at the main author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamics parameters in people with Leg Elevation and Hemodynamic Instability, run by Lazarski University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szarpak, PhD (500186225, lukasz.szarpak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output - CO (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.