UC Davis Health System
Sacramento, California, 95817, United States
Completed
NCT Number: NCT01979575
Trendelenburg Study
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Scheduled for elective surgery requiring steep trendelenburg positioning.
Exclusion criteria
- BMI >30. <18 years. Pregnancy. Prisoners.
Treatment and study plan
Primary outcomes
-
An observational study on the effects of steep Trendelenburg position and pneumoperitoneum on hemodynamic changes observed with non-invasive cardiac monitors
Time frame: One year.
Changes in cardiac output associated with patient position.
Sponsors and collaborators
Lead sponsor
University of California, Davis
Other
Registry information
Official study title
An Observational Study on the Effects of Steep Trendelenburg Position and Pneumoperitoneum on Hemodynamic Changes Observed With Non-invasive Cardiac Monitors
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Nov 8, 2013
- Registry last updated
- Oct 5, 2017
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.