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Hemodynamic Changes Due to Prone Position

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491331
Enrollment
10
Registered
2020-07-29
Start date
2020-06-08
Completion date
2020-12-20
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics Instability, Prone Position

Keywords

hemodynamics, prone position, cardiac output

Brief 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 .

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.

Interventions

PROCEDUREprone position

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.

Sponsors

University Hospital Hradec Kralove
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age \>18 years, * American Society of Anesthesiologists (ASA) Physical Status Classification I * agreement with study participation

Exclusion criteria

* disagreement with study participation, * BMI over 40 * pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Change in Cardiac Index5 minutesafter changing supine to prone position

Secondary

MeasureTime frameDescription
Changes in vena cava diameter5 minutesafter changing supine to prone position
Changes in vena jugularis diameter5 minutesafter changing supine to prone position
Changes in vena saphena diameter5 minutesafter changing supine to prone position
Changes in vena cephalica diameter5 minutesafter changing supine to prone position

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026