Clinical Trials Directory

Trials / Completed

CompletedNCT04491331

Hemodynamic Changes Due to Prone Position

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
University Hospital Hradec Kralove · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREprone 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.

Timeline

Start date
2020-06-08
Primary completion
2020-08-31
Completion
2020-12-20
First posted
2020-07-29
Last updated
2022-11-30

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT04491331. Inclusion in this directory is not an endorsement.