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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556877
Other study ID # TUTF 2018/230
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2018
Est. completion date June 15, 2020

Study information

Verified date September 2020
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Procedure:
Intraabdominal pressure and optic nerve diameters
Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG

Locations

Country Name City State
Turkey Trakya University Edirne

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary optic nerve diameter measuring optic nerve diameter within 2 hours of admission
Primary optic nerve diameter measuring optic nerve diameter at 6.hour
Primary optic nerve diameter measuring optic nerve diameter at 12.hour
Primary optic nerve diameter measuring optic nerve diameter at 24.hour
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