Hemodynamic Changes Due to Prone Position

Prone Position Clinical Trial

Official title:

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491331
• Other study ID #: UH HradecKralove
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: November 2022
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 20, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamics Instability
• Prone Position

Intervention

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.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cardiac Index	after changing supine to prone position	5 minutes
Secondary	Changes in vena cava diameter	after changing supine to prone position	5 minutes
Secondary	Changes in vena jugularis diameter	after changing supine to prone position	5 minutes
Secondary	Changes in vena saphena diameter	after changing supine to prone position	5 minutes
Secondary	Changes in vena cephalica diameter	after changing supine to prone position	5 minutes