Cataract ExtractionNCT05571683
Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection
An observational study of Cataract Extraction and Anesthesia, Local, run by Duzce University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataract Extraction, Anesthesia, Local, Optic Nerve Sheath
- What is being tested?
- oxygen support
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 16 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients for whom Intensive Care Unit (ICU) indication is prescribed
- Chronic obstructive pulmonary disease
- Past coronary arterial by-pass graft history
- Hemoglobinopathies
- Neurodegenerative diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Medicine
Düzce, Düzce, 81000
About this study
Official title: Comparison of Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes in Patients With and Without Past COVID-19 Infection Undergoing Cataract Operation
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.
Read more
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.
Read the detailed description
After the patients who meet the specified criteria are informed about the study, the volunteers who agreed to participate and signed informed consent will be included in the study.
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
- Cataract Extraction, Anesthesia, Local, Optic Nerve Sheath
- Being tested
- oxygen support
- Keywords
- cataract extraction, Anesthesia, Local, optic nerve sheath, carbon dioxide, cerebral oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: oxygen support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 times, once before acceptance in the operation room, and secondly on the end of the operation before undraping.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start6 Jun 2022
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ersoy Karka, Duzce University
- Investigators
- Özlem Ersoy Karka, Principal investigator, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571683
- Sponsor's protocol ID
- drozlemersoy1
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk K, Ersoy Karka O, Cangur S, Demir Senoglu G, Yorulmaz IS, Sezen G, Demiraran Y. Impact of ophthalmic draping on end-tidal CO(2), cerebral oximetry, and optic nerve sheath diameter in cataract surgery: an observational comparison by COVID-19 pneumonia history with randomized oxygen flow allocation. BMC Anesthesiol. 2026 Sep 1;26(1):618. doi: 10.1186/s12871-026-04213-z.
PubMed 42875739
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes in Patients With and Without Past COVID-19 Infection Undergoing Cataract Operation
- ClinicalTrials.gov ID
- NCT05571683
- Acronym / sponsor ID
- drozlemersoy1
- Conditions
- Cataract Extraction, Anesthesia, Local, Optic Nerve Sheath
- Keywords
- cataract extraction, Anesthesia, Local, optic nerve sheath, carbon dioxide, cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After the patients who meet the specified criteria are informed about the study, the volunteers who agreed to participate and signed informed consent will be included in the study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| recovered from covid-19, 2 l/min oxygen support | – | Other: oxygen support20 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. |
| no covid anamnese, 2 l/min oxygen support | – | Other: oxygen support20 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. |
| recovered from covid-19, 4 l/min oxygen support | – | Other: oxygen support20 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. |
| no covid anamnese, 4 l/min oxygen support | – | Other: oxygen support20 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Patients for whom Intensive Care Unit (ICU) indication is prescribed
- Chronic obstructive pulmonary disease
- Past coronary arterial by-pass graft history
- Hemoglobinopathies
- Neurodegenerative diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen support40 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. | Other | 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 |
Primary outcome
Change from baseline in the end tidal carbon dioxide values
Time frame: 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.
End tidal carbondioxide values will be measured continously during the operation with a capnograph device via nasal cannula non-invasively and recorded.
Change from baseline in the cerebral oxygenisation values
Time frame: 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.
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.
Change from baseline in the optic nerve sheath diameter
Time frame: 2 times, once before acceptance in the operation room, and secondly on the end of the operation before undraping.
The optic nerve sheath diameter will be measured ultrasonographically by the same experienced researcher before and on the end of the operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 42875739Ozturk K, Ersoy Karka O, Cangur S, Demir Senoglu G, Yorulmaz IS, Sezen G, Demiraran Y. Impact of ophthalmic draping on end-tidal CO(2), cerebral oximetry, and optic nerve sheath diameter in cataract surgery: an observational comparison by COVID-19 pneumonia history with randomized oxygen flow allocation. BMC Anesthesiol. 2026 Sep 1;26(1):618. doi: 10.1186/s12871-026-04213-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Ersoy Karka principal investigator
Düzce University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Extraction and Anesthesia, Local, run by Duzce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the end tidal carbon dioxide values (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.