Hemodynamic Changes Due to Prone Position

Completed

• Conditions: Prone Position; Hemodynamics Instability
• Interventions: Procedure: prone position

• Registration Number: NCT04491331
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study Start: 2020-06-08
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-anesthetized volunteers	prone position	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.

Primary Outcome Measures

Name	Time	Method
Change in Cardiac Index	5 minutes	after changing supine to prone position

Secondary Outcome Measures

Name	Time	Method
Changes in vena jugularis diameter	5 minutes	after changing supine to prone position
Changes in vena cava diameter	5 minutes	after changing supine to prone position
Changes in vena saphena diameter	5 minutes	after changing supine to prone position
Changes in vena cephalica diameter	5 minutes	after changing supine to prone position

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia