Different Intra-abdominal Pressures and Optic Nerve Size

Investigation of the Effects of Different Intra-abdominal Pressures on Optic Nerve Size Measured by Orbital USG in Patients Undergoing Major Abdominal Surgery

In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.

Study Overview

• Status: Completed
• Conditions: Major Surgery; Intraabdominal Hypertension; Optic Nerve Congestion
• Intervention / Treatment: Procedure: Intraabdominal pressure and optic nerve diameters

Detailed Description

In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. This situation creates ischemia in the abdominal organs in the patient, decreases venous return as a result of inferior vena cava compression and leads to a decrease in cardiac output. In addition, intracranial pressure frequently increases as a result of the venous circulation being affected. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Postoperative patients followed in intensive care

Description

Inclusion Criteria:

Having had major abdominal surgery

Exclusion Criteria:

1. pregnant patients
2. Patients whose bladder catheter cannot be inserted
3. Patients with diagnosed or suspected brain death

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intraabdominal pressure under 12 mmHg; Patients with intraabdominal pressure under 12 mmHg	Procedure: Intraabdominal pressure and optic nerve diameters; Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG
Intraabdominal pressure between 12-20 mmHg; Patients with intraabdominal pressure between 12-20 mmHg	Procedure: Intraabdominal pressure and optic nerve diameters; Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG
Intraabdominal pressure over 20 mmHg; Patients with intraabdominal pressure over 20 mmHg	Procedure: Intraabdominal pressure and optic nerve diameters; Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
optic nerve diameter	measuring optic nerve diameter	within 2 hours of admission
optic nerve diameter	measuring optic nerve diameter	at 6.hour
optic nerve diameter	measuring optic nerve diameter	at 12.hour
optic nerve diameter	measuring optic nerve diameter	at 24.hour

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): June 15, 2020
• Study Completion (ACTUAL): June 15, 2020

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: TUTF 2018/230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No