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Completed

NCT Number: NCT04491331

Hemodynamic Changes Due to Prone Position

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 .

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Key information

Conditions

Hemodynamics Instability Prone Position

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prone position

Procedure

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.

Primary outcomes

  1. Change in Cardiac Index

    Time frame: 5 minutes

    after changing supine to prone position

Secondary outcomes

  1. Changes in vena cava diameter

    Time frame: 5 minutes

    after changing supine to prone position

  2. Changes in vena jugularis diameter

    Time frame: 5 minutes

    after changing supine to prone position

  3. Changes in vena saphena diameter

    Time frame: 5 minutes

    after changing supine to prone position

  4. Changes in vena cephalica diameter

    Time frame: 5 minutes

    after changing supine to prone position

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

Hemodynamic Changes Due to Prone Position in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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