Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection
NCT ID: NCT05571683
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2022-06-06
2023-12-16
Brief Summary
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As the optic nerve sheath is an extension of the brain dura mater, the diameter of the sheath expands in case of increased intracranial pressure. Evaluation of the optic nerve sheath with ultrasound allows us to obtain information about intracranial pressure. For optic nerve sheath diameter, measurements above 5.0 mm in adult patients are generally considered as increased intracranial pressure.
COVID-19 is a global epidemic caused by SARS-CoV-2 that we are still fighting. Although it is a multisystemic disease, it is important in terms of its effects on pulmonary function and the continuity of pulmonary symptoms and findings after this disease has been overcome.
In our study, End-Tidal CO2 and cerebral oximetry (NIRS) values will be determined and compared between the groups that received 2lt/min and 4lt/min nasal oxygen support during cataract surgery performed using draping under local anesthesia in patients who had COVID-19, recovered and never had. It was aimed to evaluate and compare the values of optic nerve sheath diameter increase.
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Detailed Description
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After all volunteers are taken to the operation room, vascular access will be established, electrocardiography, pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide and cerebral oximetry (with the neck in the supine position in the neutral position and 2 probes placed on the forehead) are monitored without any medication (Figure 1). The optic nerve sheath diameter will be measured by the ultrasonography device in the inventory of the Department of Anesthesiology and Reanimation by the researchers, basal heart rate (CTA), peripheral oxygen saturation (SpO2), systolic (SBP) and diastolic blood pressure (DBP), end- Tidal carbon dioxide (ETCO2), cerebral oxygen saturation (SO) values will be recorded. All measurements except optic nerve sheath diameter will be recorded and repeated at 5 minute intervals throughout the operation. During this time, no drugs or invasive methods will be used.
During the operation, the volunteers in both groups will be randomly divided into 2 subgroups and 2L/min and 4 L/min nasal oxygen support will be provided. At the end of the operation, the ultrasonographic optic nerve sheath diameter measurement will be repeated immediately after the dressing is removed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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recovered from covid-19, 2 l/min oxygen support
20 patients, who recovered from COVID-19 will be supported with 2 l/min oxygen during the operation under the drapes. Electrocardiography, pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide and cerebral oximetry will be monitored and optic nerve sheath diameter will be measured before and after surgical procedure. All measurements except optic nerve sheath diameter will be recorded and repeated at 5 minute intervals throughout the operation.
oxygen support
40 patients (2 arms) will be supported with 2 l/min oxygen and the other 2 arms (40 patients) will be supported with 4 l/min oxygen under the surgical drapes.
no covid anamnese, 2 l/min oxygen support
20 patients with no COVID-19 anamnese will be supported with 2 l/min oxygen during the operation under the drapes. Electrocardiography, pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide and cerebral oximetry will be monitored and optic nerve sheath diameter will be measured before and after surgical procedure. All measurements except optic nerve sheath diameter will be recorded and repeated at 5 minute intervals throughout the operation.
oxygen support
40 patients (2 arms) will be supported with 2 l/min oxygen and the other 2 arms (40 patients) will be supported with 4 l/min oxygen under the surgical drapes.
recovered from covid-19, 4 l/min oxygen support
20 patients, who recovered from COVID-19 will be supported with 4 l/min oxygen during the operation under the drapes. Electrocardiography, pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide and cerebral oximetry will be monitored and optic nerve sheath diameter will be measured before and after surgical procedure. All measurements except optic nerve sheath diameter will be recorded and repeated at 5 minute intervals throughout the operation.
oxygen support
40 patients (2 arms) will be supported with 2 l/min oxygen and the other 2 arms (40 patients) will be supported with 4 l/min oxygen under the surgical drapes.
no covid anamnese, 4 l/min oxygen support
20 patients with no COVID-19 anamnese will be supported with 4 l/min oxygen during the operation under the drapes. Electrocardiography, pulse oximetry, non-invasive blood pressure, end-tidal carbon dioxide and cerebral oximetry will be monitored and optic nerve sheath diameter will be measured before and after surgical procedure. All measurements except optic nerve sheath diameter will be recorded and repeated at 5 minute intervals throughout the operation.
oxygen support
40 patients (2 arms) will be supported with 2 l/min oxygen and the other 2 arms (40 patients) will be supported with 4 l/min oxygen under the surgical drapes.
Interventions
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oxygen support
40 patients (2 arms) will be supported with 2 l/min oxygen and the other 2 arms (40 patients) will be supported with 4 l/min oxygen under the surgical drapes.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Chronic obstructive pulmonary disease
* Past coronary arterial by-pass graft history
* Hemoglobinopathies
* Neurodegenerative diseases
18 Years
80 Years
ALL
No
Sponsors
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Duzce University
OTHER
Responsible Party
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Özlem Ersoy Karka
Assistant Professor
Principal Investigators
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Özlem Ersoy Karka
Role: PRINCIPAL_INVESTIGATOR
Düzce University Faculty of Medicine
Locations
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Duzce University Faculty of Medicine
Düzce, Düzce, Turkey (Türkiye)
Countries
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Other Identifiers
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drozlemersoy1
Identifier Type: -
Identifier Source: org_study_id
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