Hemodynamic Changes Due to Prone Position

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

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 .

Study Overview

• Status: Completed
• Conditions: Prone Position; Hemodynamics Instability
• Intervention / Treatment: Procedure: prone position

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Czechia
  • Hradec Kralove, Czechia, 50005
    • University hospital Hradec Králové

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

6 male and 6 female healthy, non-anesthetized volunteers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-anesthetized volunteers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Index	after changing supine to prone position	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in vena cava diameter	after changing supine to prone position	5 minutes
Changes in vena jugularis diameter	after changing supine to prone position	5 minutes
Changes in vena saphena diameter	after changing supine to prone position	5 minutes
Changes in vena cephalica diameter	after changing supine to prone position	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove
• Investigators: Study Director: Lucie Kukralova, MD, UH Hradec Kralove

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hemodynamics; prone position; cardiac output
• Other Study ID Numbers: UH HradecKralove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No