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Clinical Trials/NCT04491331
NCT04491331
Completed
Not Applicable

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

University Hospital Hradec Kralove1 site in 1 country10 target enrollmentJune 8, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodynamics Instability
Sponsor
University Hospital Hradec Kralove
Enrollment
10
Locations
1
Primary Endpoint
Change in Cardiac Index
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2020
End Date
December 20, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dostalova Vlasta, MD, PhD

Principal investigator

University Hospital Hradec Kralove

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Cardiac Index

Time Frame: 5 minutes

after changing supine to prone position

Secondary Outcomes

  • Changes in vena jugularis diameter(5 minutes)
  • Changes in vena cava diameter(5 minutes)
  • Changes in vena saphena diameter(5 minutes)
  • Changes in vena cephalica diameter(5 minutes)

Study Sites (1)

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