Trendelenburg Study

An Observational Study on the Effects of Steep Trendelenburg Position and Pneumoperitoneum on Hemodynamic Changes Observed With Non-invasive Cardiac Monitors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01979575

Enrollment

Registered

2013-11-08

Start date

2013-10-31

Completion date

2015-07-31

Last updated

2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of Non-invasive Monitors of Cardiac Function

Keywords

Nexfin, Flotrac, Esophageal, Cardiac output

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Scheduled for elective surgery requiring steep trendelenburg positioning.

Exclusion criteria

* BMI \>30. \<18 years. Pregnancy. Prisoners.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results