Trendelenburg's Slide Prevention Study (SPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Ellen Wechter, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01068821
First received: February 12, 2010
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Misadventure During Surgical Operation
Postoperative Complications
Other: Gel pad
Other: Egg crate foam mattress

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing Commonly Used Techniques to Prevent Slippage During Steep Trendelenburg's Position

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Amount of Patient Movement on the Operating Room Table [ Time Frame: About 150 minutes after start of surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery [ Time Frame: postoperative day 1 and postoperative week 3-8 ] [ Designated as safety issue: Yes ]
    The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.


Enrollment: 60
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Egg crate foam mattress
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
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.
Other Names:
  • Pink Foam:
  • Kendall Company, Ref# 31163457
Active Comparator: Gel pad
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
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 Names:
  • Gel Pad:
  • Allen Medical

Detailed Description:

Patient undergoing laparoscopic gynecologic surgery are often placed in steep (30 to 45 degrees) Trendelenburg's (head lower than feet) position. This helps the bowels to move towards the patient's head, making surgery in the pelvis safer. During surgery, if patients slide a great deal toward the head of the bed, nerve injury and hernia risk may be increased. Several techniques are in use to prevent patients from sliding on the bed during surgery, and of these, increasing the friction between a patient's skin and the bed surface appears to be the safest technique. Two materials are in use to increase this friction: a gel pad or an egg-crate foam mattress upon which the patient lies with bare skin. This study is comparing these two materials to see which material is associated with the LEAST amount of patient slide. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with intolerance of Trendelenburg's position
  • Patients whose surgery are converted to laparotomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068821

Locations
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32233
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mary E Wechter, MD, MPH Mayo Clinic, Baptist Medical Center
  More Information

Publications:
Responsible Party: Mary Ellen Wechter, Independent Physician, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01068821     History of Changes
Other Study ID Numbers: 09-000685-01
Study First Received: February 12, 2010
Results First Received: August 15, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Slide
Trendelenburg's position
Postoperative
neurologic complaints

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014