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

Sponsor

Marmara University (Other)

Overall Status

Terminated

CT.gov ID

NCT03938402

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

Changes in intraocular pressure [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.
Changes in optic nerve sheath diameter [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Marmara University School of Medicine	Istanbul	Pendik	Turkey	34899

Sponsors and Collaborators

Marmara University

Investigators

Principal Investigator: Ruslan Abdullayev, Marmara University School of Medicine, Dep of Anesthesiology and Reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruslan Abdullayev, Assist. Prof., Marmara University

ClinicalTrials.gov Identifier:

NCT03938402

Other Study ID Numbers:

09.2019.378

First Posted:

May 6, 2019

Last Update Posted:

Dec 3, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ruslan Abdullayev, Assist. Prof., Marmara University

Intraocular pressure

Optic nerve sheath diameter

Positive end-expiratory pressure

Study Results

No Results Posted as of Dec 3, 2021