Trendelenburg's Slide Prevention Study

NCT01068821 | Completed Results

• 1 other identifier: 09-000685-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Slide; Trendelenburg's position; Postoperative; neurologic complaints

Outcome Measures

Primary Outcomes (1)

• Amount of Patient Movement on the Operating Room Table

  Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.

  About 150 minutes after start of surgery

Secondary Outcomes (1)

• Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery

  postoperative day 1 and postoperative week 3-8

Study Arms (2)

Egg crate foam mattress

ACTIVE COMPARATOR

Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).

Other: Egg crate foam mattress

Gel pad

ACTIVE COMPARATOR

Patients will be placed on gel pad instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).

Other: Gel pad

Interventions

Gel pad OTHER

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.

Also known as: Gel Pad:, Allen Medical

Gel pad

Egg crate foam mattress OTHER

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.

Also known as: Pink Foam:, Kendall Company, Ref# 31163457

Egg crate foam mattress

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing gynecologic laparoscopic or robotic-assisted laparoscopic surgery
• Trendelenburg's position is planned
• General anesthesia is planned

You may not qualify if:

• Patients with intolerance of Trendelenburg's position
• Patients whose surgery are converted to laparotomy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32233, United States

Location

Related Publications (1)

• Klauschie J, Wechter ME, Jacob K, Zanagnolo V, Montero R, Magrina J, Kho R. Use of anti-skid material and patient-positioning to prevent patient shifting during robotic-assisted gynecologic procedures. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):504-7. doi: 10.1016/j.jmig.2010.03.013. Epub 2010 May 14.

  PMID: 20471916 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Evaluation of postoperative outcomes was non-systematic using chart review for all participants except for one participant whose identity was not listed on data abstraction sheet.

Results Point of Contact

• Title: Dr. Mary Ellen Wechter
• Organization: Mayo Clinic, Florida

wechter.mary@mayo.edu

904 412 7351

Study Officials

• Mary E Wechter, MD, MPH

  Mayo Clinic, Baptist Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent Physician

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 15, 2012
• Results First Posted: May 15, 2012

Record last verified: 2012-04

Locations

US (1)