A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients

NCT01737645 | Terminated DMC

• 1 other identifier: 2011-273
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.

Conditions

Intraocular Pressure Disorder

Outcome Measures

Primary Outcomes (1)

• To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.

  Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.

Secondary Outcomes (2)

• To determine rate of rise of IOP during steep Trendelenburg positioning

  The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.

• To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.

  The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.

Study Arms (2)

obese patients

BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres)

Thin patients

BMI less than or equal to 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Subjects undergoing prolonged procedures expected to be in steep Trendelenburg position. Procedure must be scheduled for \> 3 hours, eg. robotic prostatectomy, hysterectomy, and cystectomy.

You may qualify if:

• Subjects undergoing prolonged procedures (scheduled \>3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
• Morbidly obese subjects: BMI ≥ 35 kg/m2
• Thin subjects: BMI ≤ 30 kg/m2
• Age 18-70
• ASA (American Society of Anesthesiologists) physical status classification I, II, or III

You may not qualify if:

• Known history of glaucoma
• Note:if initial IOP is noted to be \>21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
• Recent use of IOP lowering topical ophthalmic agents
• Allergy to latex or proparacaine hydrochloride ophthalmic solution
• Patients with active corneal epithelial defects or history of recurrent corneal erosion
• Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology)
• History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
• Any eye surgery within prior 1 month
• Known pregnancy
• Cognitive impairment

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Study Officials

• Roy G Soto, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: November 29, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

US (1)