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

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ClinicalTrials.gov Identifier: NCT03938402
Recruitment Status : Terminated (As a result of COVID-19 pandemics)
First Posted : May 6, 2019
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ruslan Abdullayev, Marmara University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Intracranial Pressure Positive End-expiratory Pressure Other: Positive end-expiratory pressure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938402


Locations
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Turkey
Marmara University School of Medicine
Istanbul, Pendik, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
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Principal Investigator: Ruslan Abdullayev Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
More Information
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Responsible Party: Ruslan Abdullayev, Assist. Prof., Marmara University
ClinicalTrials.gov Identifier: NCT03938402    
Other Study ID Numbers: 09.2019.378
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ruslan Abdullayev, Marmara University:
Intraocular pressure
Optic nerve sheath diameter
Positive end-expiratory pressure