Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection

NCT05571683 | Completed

• 1 other identifier: drozlemersoy1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Today, phacoemulsification has become the most commonly applied method in the treatment of cataract, which is considered as a public health problem. Since the eyelid margins can be a source for pathogens in phacoemulsification surgery draping after skin sterilization is applied to remove the eyelashes from the operation area. Since surgical drapes are airtight, carbon dioxide (CO2) accumulation occurs under the drape in patients under local anesthesia. During the operation, if the end tidal CO2 pressure value rises, this can lead to hyperventilation and tachycardia and also increase the intraocular pressure which is undesirable in eye surgery. In our study, in order to observe and compare undesirable conditions, regional tissue oxygenation saturation (rSO2) will be determined non-invasively with Transcutaneous Near Infrared Spectroscopy (NIRS) technology , which allows real-time monitoring. Changes in the partial pressure of carbon dioxide (PaCO2) are strongly vaso-active, resulting in changes in cerebral blood volume and hence intracranial pressure. 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.

Conditions

Cataract Extraction; Anesthesia, Local; Optic Nerve Sheath

Keywords

cataract extraction; Anesthesia, Local; optic nerve sheath; carbon dioxide; cerebral oxygen saturation

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the end tidal carbon dioxide values

  End tidal carbondioxide values will be measured continously during the operation with a capnograph device via nasal cannula non-invasively and recorded.

  End tidal carbondioxide values will be measured continously during the operation and recorded in every 5 minutes from the draping to the end of the operation.

• Change from baseline in the cerebral oxygenisation values

  Cerebral oxygenisation values will be measured continously during the operation with a transcutaneous near infrared spectroscope device (NIRS) via a transcutaneous probe placed on the frontal bone non-invasively and recorded.

  Cerebral oxygenisation values will be measured continously during the operation and recorded in every 5 minutes from the draping to the end of the operation.

• Change from baseline in the optic nerve sheath diameter

  The optic nerve sheath diameter will be measured ultrasonographically by the same experienced researcher before and on the end of the operation.

  2 times, once before acceptance in the operation room, and secondly on the end of the operation before undraping.

Study Arms (4)

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.

Other: oxygen support

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.

Other: oxygen support

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.

Other: oxygen support

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.

Other: oxygen support

Interventions

oxygen support OTHER

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; no covid anamnese, 4 l/min oxygen support; recovered from covid-19, 2 l/min oxygen support; recovered from covid-19, 4 l/min oxygen support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 80 patients who will undergo phacoemulsification surgery under local anesthesia will be included in the study. 40 of the patients will be individuals who have had Covid-19 infection and recovered, and 40 will be individuals who have not had Covid-19 infection.

You may qualify if:

• Patients over the age of 18 who will undergo cataract surgery, who are in I, II and III risk groups according to the American Society of Anesthesiologists (ASA) classification

You may not qualify if:

• Patients for whom Intensive Care Unit (ICU) indication is prescribed
• Chronic obstructive pulmonary disease
• Past coronary arterial by-pass graft history
• Hemoglobinopathies
• Neurodegenerative diseases

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine

Düzce, Düzce, 81000, Turkey (Türkiye)

Location

Study Officials

• Özlem Ersoy Karka

  Düzce University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: June 6, 2022
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)