Hemodynamic Changes Due to Prone Position

NCT04491331 | Completed

• 1 other identifier: UH HradecKralove
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 .

Conditions

Hemodynamics Instability; Prone Position

Keywords

hemodynamics; prone position; cardiac output

Outcome Measures

Primary Outcomes (1)

• Change in Cardiac Index

  after changing supine to prone position

  5 minutes

Secondary Outcomes (4)

• Changes in vena cava diameter

  5 minutes

• Changes in vena jugularis diameter

  5 minutes

• Changes in vena saphena diameter

  5 minutes

• Changes in vena cephalica diameter

  5 minutes

Study Arms (1)

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

Interventions

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.

Non-anesthetized volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

6 male and 6 female healthy, non-anesthetized volunteers

You may qualify if:

• age \>18 years,
• American Society of Anesthesiologists (ASA) Physical Status Classification I
• agreement with study participation

You may not qualify if:

• disagreement with study participation,
• BMI over 40
• pregnancy

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Related 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.

  BACKGROUND

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lucie Kukralova, MD

  UH Hradec Kralove

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: June 8, 2020
• Primary Completion: August 31, 2020
• Study Completion: December 20, 2020
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)