Trendelenburg Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Comparison of Non-invasive Monitors of Cardiac Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled for elective surgery requiring steep trendelenburg positioning.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UC Davis Health System

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

495567

Identifier Type: -

Identifier Source: org_study_id