An observational study in Hemodynamics Instability and Prone Position, sponsored by University Hospital Hradec Kralove. Completed at 1 site in Czechia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by University Hospital Hradec Kralove · Observational
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 .
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.
University Hospital Hradec Kralove is the lead sponsor of 46 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
6 male and 6 female healthy, non-anesthetized volunteers
Exclusion Criteria:
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.
Procedure: prone 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.
Change in Cardiac Index
after changing supine to prone position
Time frame: 5 minutes
Changes in vena cava diameter
after changing supine to prone position
Time frame: 5 minutes
Changes in vena jugularis diameter
after changing supine to prone position
Time frame: 5 minutes
Changes in vena saphena diameter
after changing supine to prone position
Time frame: 5 minutes
Changes in vena cephalica diameter
after changing supine to prone position
Time frame: 5 minutes
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Hradec Kralove