Two eye care methods to prevent eye problems in ventilated ICU patients
Effects of Two Different Eye Care Practices on Eye Complications in Mechanically Ventilated Intensive Care Patients
NA · Istanbul Saglik Bilimleri University · NCT07070843
This tests whether using an eye care kit, a written eye-care protocol, or both will reduce eye complications compared with standard care in adults on mechanical ventilation in the ICU.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Days and up |
| Sex | All |
| Sponsor | Istanbul Saglik Bilimleri University (other) |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07070843 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial that assigns mechanically ventilated ICU patients to one of four groups: standard care, an eye care kit, a written eye-care protocol, or both kit and protocol. ICU nurses receive training on the kit and the protocol, and care is delivered on a regular schedule with daily ocular risk assessment and documentation. The study tracks development of ocular complications such as exposure keratopathy and infection while recording changes in eye condition and notifying physicians as needed. Outcomes compare the frequency of eye complications across the four approaches.
Who should consider this trial
Good fit: Adults (18+) who are receiving mechanical ventilation in the ICU, have a Glasgow Coma Scale below 12, have been in the ICU at least 24 hours, and have baseline tear production greater than 5 mm on the Schirmer test.
Not a fit: Patients with existing ocular infection, chemosis, facial or eye trauma, recent brain surgery, brain death, or those extubated before completing the care period are unlikely to benefit from the interventions as studied.
Why it matters
Potential benefit: If successful, the tested methods could lower the rate of corneal injury, infections, and other eye complications in ventilated ICU patients and protect vision.
How similar studies have performed: Previous trials of protocolized eye care, eyelid closure, and lubrication have shown reductions in exposure keratopathy and related complications, though combined kit-plus-protocol approaches have been less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Receiving mechanical ventilation * Glasgow Coma Scale (GCS) score \< 12 * At least 24 hours have passed since ICU admission * Baseline Schirmer test result indicating tear production \> 5 mm prior to study inclusion Exclusion Criteria: * Diagnosed with brain death * Presence of facial or ocular trauma * Patients with head trauma * Patients who have undergone brain surgery * Patients diagnosed with an eye infection or chemosis Withdrawal Criteria: * Patient's death during the study period * Extubation of the patient before completion of the care period
Where this trial is running
Istanbul, Istanbul
- University of Health Sciences (Sağlık Bilimleri Üniversitesi) — Istanbul, Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Yildiz Deniz — University of Health Sciences (Sağlık Bilimleri Üniversitesi)
- Study coordinator: Yildiz Deniz
- Email: yildizdeniz142@gmail.com
- Phone: +905387251394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eye Care, Nursing Care, Intensive Care Unit, Critical care nursing, Eye infections, Intensive care units, Nursing care