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Trendelenburg's Slide Prevention Study

NCT01068821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-05-15

Study results available
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Summary

The purpose of this study is to compare two cushioning materials (a gel mattress and an egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent patients from sliding toward the head of the bed during head-down positioning.

Our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (\<2 inches) on average.

Conditions

  • Misadventure During Surgical Operation
  • Postoperative Complications

Interventions

OTHER

Gel pad

A gel pad (mattress) (approximately 3cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.

OTHER

Egg crate foam mattress

An egg-crate foam mattress (approximately 5cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.

Sponsors & Collaborators

Principal Investigators

  • Mary E Wechter, MD, MPH · Mayo Clinic, Baptist Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068821 on ClinicalTrials.gov