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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03938402
Other study ID # 09.2019.378
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
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