Last reviewed · How we verify
NCT05571683
Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection
trial testing oxygen support in Cataract Extraction in 80 participants. Completed in 16 December 2023.
16 December 2023
Quick facts
| Lead sponsor | Duzce University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 6 June 2022 |
| Primary completion | 16 December 2023 |
| Estimated completion | 16 December 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- oxygen support
Conditions studied
- Cataract Extraction — all drugs for Cataract Extraction →
- Anesthesia, Local — all drugs for Anesthesia, Local →
- Optic Nerve Sheath — all drugs for Optic Nerve Sheath →
Sponsor
Duzce University
Who can join
Adults 18 to 80, any sex, with Cataract Extraction or Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05571683
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cataract Extraction
Currently open trials in the same condition.
- NCT07305987 — PRO-232 in Patients Subjected to Cataract Surgery · Phase 3 · recruiting
Other Duzce University trials
Trials by the same sponsor.
- NCT07300176 — Virtual Reality-Assisted Intraoperative Sensory Modulation on Postpartum Depression and the Kynurenine Pathway · active not recruiting
- NCT07163468 — Neuromusculoskeletal Alterations After ACL Injury · completed
- NCT07468240 — Mindfulness-Based Psychoeducation for Burnout, Decision-Making, and Existential Anxiety in High-Risk Unit Nurses · NA · completed
- NCT07152093 — Development of an Artificial Intelligence-Based Model for Predicting Difficult Intubation Using Video Laryngoscopic Imag · completed
- NCT07057362 — Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05571683 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duzce University
- Last refreshed: 13 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05571683.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing