Trendelenburg Study

Completed

• Conditions: Comparison of Non-invasive Monitors of Cardiac Function

• Registration Number: NCT01979575
• Lead Sponsor: University of California, Davis

Brief Summary

1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures.

Detailed Description

This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the hemodynamic and cardiovascular effects of the steep Trendelenburg position on non-invasive or minimally invasive monitors used in the operating room during surgical procedures requiring this patient position.

SPECIFIC AIMS: 1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position. 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures.

HYPOTHESIS: Hemodynamic and cardiovascular changes during alterations in position from supine to steep Trendelenburg and intra-abdominal insufflation measured by non-invasive and minimally invasive monitors will correlate with transthoracic echocardiographic measurements.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Primary Completion: 2014-09
• Study Completion: 2015-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Scheduled for elective surgery requiring steep trendelenburg positioning.

Exclusion Criteria

• BMI >30. <18 years. Pregnancy. Prisoners.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An observational study on the effects of steep Trendelenburg position and pneumoperitoneum on hemodynamic changes observed with non-invasive cardiac monitors	One year.	Changes in cardiac output associated with patient position.

Trial Locations

Locations (1)

UC Davis Health System; 🇺🇸 Sacramento, California, United States