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

NCT ID: NCT03938402

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intraocular Pressure Intracranial Pressure Positive End-expiratory Pressure

Keywords

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Intraocular pressure Optic nerve sheath diameter Positive end-expiratory pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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PEEP 5

Group Type EXPERIMENTAL

Positive end-expiratory pressure

Intervention Type OTHER

Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.

PEEP 10

Group Type EXPERIMENTAL

Positive end-expiratory pressure

Intervention Type OTHER

Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.

PEEP 15

Group Type EXPERIMENTAL

Positive end-expiratory pressure

Intervention Type OTHER

Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Ruslan Abdullayev

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruslan Abdullayev

Role: PRINCIPAL_INVESTIGATOR

Marmara University School of Medicine, Dep of Anesthesiology and Reanimation

Locations

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Marmara University School of Medicine

Istanbul, Pendik, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2019.378

Identifier Type: -

Identifier Source: org_study_id