Hemodynamics InstabilityNCT04491331
Hemodynamic Changes Due to Prone Position
An observational study of Hemodynamics Instability and Prone Position, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
Perioperative prone position may be associated with hemodynamic instability. The causes of instability have not yet been precisely elucidated. The aim of this study is to demonstrate physiological changes during prone positioning in healthy volunteers . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics Instability, Prone Position
- What is being tested?
- prone position
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Jun 2020to 20 Dec 2020
- Phase
- Observational
- 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
Study population: 6 male and 6 female healthy, non-anesthetized volunteers
Who may be able to join
- age >18 years,
- American Society of Anesthesiologists (ASA) Physical Status Classification I
- agreement with study participation
Who cannot join
- disagreement with study participation,
- BMI over 40
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Changes Due to Prone Position in Healthy Volunteers
Perioperative prone position may be associated with hemodynamic instability. The causes of instability have not yet been precisely elucidated. The aim of this study is to demonstrate physiological changes during prone positioning in healthy volunteers .
Read the detailed description
The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained by increased systemic vascular resistance (SVR) in the majority of patients.
The aim of this study is to describe hemodynamic changes in two different surgical prone positions in 10 healthy non-anesthetized volunteers (flat position and using a support system allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards) and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger cuff.
- Conditions
- Hemodynamics Instability, Prone Position
- Being tested
- prone position
- Keywords
- hemodynamics, prone position, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positionProcedure or surgery
Unsupported prone position with arms along the body in neutral position will be used first without any supportive device except support of heels with a soft cylindrical device, head will be held in a neutral position using prone head rest. After recording of all measered values, the prone position using the prone position support system will be tested. The support system allows free movement of the lower thorax and abdomenal wall, upper arms are elevated and angled in 90 degrees (in shoulders and elbows). Heels will be positioned at the level of the heart using a supportive cylindrical device. Head will be held in a neutral position using prone head rest.
| Study group | Role | What they receive |
|---|---|---|
| Non-anesthetized volunteers | Hemodynamic parameters will be measured in supine position. Volunteers will be turned into prone position. After a five-minute stabilization phase will be monitored CI, MAP, heart rate (HR), stroke volume variation SVV, systemic vascular resistance index (SVRI) by non-invasive measurements using a ClearSight (Edwards) in two prone positions (lying on support system allowing a free abdomen and then lying flat without any device). Furthermore, the width of the inferior vena cava and vena jugularis interna, vena saphena and vena cephalica will be measured by ultrasound. The measurement will be performed in inspiration and in expiration phase. Receives: Procedure: prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac Index
after changing supine to prone position
Measured: 5 minutes
Secondary outcomes (4)
Changes in vena cava diameter
after changing supine to prone position
Measured: 5 minutes
Changes in vena jugularis diameter
after changing supine to prone position
Measured: 5 minutes
Changes in vena saphena diameter
after changing supine to prone position
Measured: 5 minutes
Changes in vena cephalica diameter
after changing supine to prone position
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start8 Jun 2020
- Primary completion31 Aug 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamics InstabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Lucie Kukralova, MD, Study director, UH Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491331
- Sponsor's protocol ID
- UH HradecKralove
- Status last verified
- Nov 2022
- First submitted
- 24 Jul 2020
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kukrálová L, Dostálová V, Dostál P. Hemodynamic changes in prone position - a non-invasive physiological study. Anest. intenziv. Med.. 2021;32(2):82-86. doi: 10.36290/aim.2021.010.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes Due to Prone Position in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04491331
- Acronym / sponsor ID
- UH HradecKralove
- Conditions
- Hemodynamics Instability, Prone Position
- Keywords
- hemodynamics, prone position, cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 29 Jul 2020 (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.
Perioperative prone position may be associated with hemodynamic instability. The causes of instability have not yet been precisely elucidated. The aim of this study is to demonstrate physiological changes during prone positioning in healthy volunteers .
Detailed description
The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained by increased systemic vascular resistance (SVR) in the majority of patients.
The aim of this study is to describe hemodynamic changes in two different surgical prone positions in 10 healthy non-anesthetized volunteers (flat position and using a support system allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards) and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger cuff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-anesthetized volunteers | – | Procedure: prone positionHemodynamic parameters will be measured in supine position. Volunteers will be turned into prone position. After a five-minute stabilization phase will be monitored CI, MAP, heart rate (HR), stroke volume variation SVV, systemic vascular resistance index (SVRI) by non-invasive measurements using a ClearSight (Edwards) in two prone positions (lying on support system allowing a free abdomen and then lying flat without any device). Furthermore, the width of the inferior vena cava and vena jugularis interna, vena saphena and vena cephalica will be measured by ultrasound. The measurement will be performed in inspiration and in expiration phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 6 male and 6 female healthy, non-anesthetized volunteers
Key inclusion criteria (3 listed)
- age >18 years,
- American Society of Anesthesiologists (ASA) Physical Status Classification I
- agreement with study participation
Key exclusion criteria (3 listed)
- disagreement with study participation,
- BMI over 40
- pregnancy
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 |
|---|---|---|
| prone positionUnsupported prone position with arms along the body in neutral position will be used first without any supportive device except support of heels with a soft cylindrical device, head will be held in a neutral position using prone head rest. After recording of all measered values, the prone position using the prone position support system will be tested. The support system allows free movement of the lower thorax and abdomenal wall, upper arms are elevated and angled in 90 degrees (in shoulders and elbows). Heels will be positioned at the level of the heart using a supportive cylindrical device. Head will be held in a neutral position using prone head rest. | Procedure or surgery | Non-anesthetized volunteers |
Primary outcome
Change in Cardiac Index
Time frame: 5 minutes
after changing supine to prone position
4 secondary outcomes
Changes in vena cava diameter
Time frame: 5 minutes
Changes in vena jugularis diameter
Time frame: 5 minutes
Changes in vena saphena diameter
Time frame: 5 minutes
Changes in vena cephalica diameter
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- BackgroundKukrálová L, Dostálová V, Dostál P. Hemodynamic changes in prone position - a non-invasive physiological study. Anest. intenziv. Med.. 2021;32(2):82-86. doi: 10.36290/aim.2021.010.
- Individual participant dataSharing planned: No
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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.
Lucie Kukralova, MD study director
UH Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics Instability and Prone Position, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 3 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: finished, as of the sponsor's last update on 30 Nov 2022. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiac Index (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491331, which also lists 1 linked publication.
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 30 Nov 2022.