Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels

November 22, 2021 updated by: Ruslan Abdullayev, Marmara University

Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery

Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pendik
      • Istanbul, Pendik, Turkey, 34899
        • Marmara University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing laparotomy for gastrointestinal surgery
  • American Society of Anesthesiologists (ASA) 1 or 2 physical status
  • Elective surgery

Exclusion Criteria:

  • Patients with glaucoma
  • ASA 3 or over physical status
  • Emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEEP 5
Other: Positive end-expiratory pressure
Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.
EXPERIMENTAL: PEEP 10
Other: Positive end-expiratory pressure
Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.
EXPERIMENTAL: PEEP 15
Other: Positive end-expiratory pressure
Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in intraocular pressure
Time Frame: Throughout the operation (usually about 1.5 hours).
The physiological value for intraocular pressure is 10-20 mm Hg. Changes in intraocular pressure will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Throughout the operation (usually about 1.5 hours).
Changes in optic nerve sheath diameter
Time Frame: Throughout the operation (usually about 1.5 hours).
Changes in optic nerve sheath diameter will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Throughout the operation (usually about 1.5 hours).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

April 27, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09.2019.378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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