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

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03938402
• Other study ID #: 09.2019.378
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intracranial Pressure
• Intraocular Pressure
• Positive End-expiratory Pressure

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in intraocular pressure	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).
Primary	Changes in optic nerve sheath diameter	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).