Clinical trial NCT05874453: Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
Official title: Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Complications
Eye Protocol
Keywords: eye protocol
ocular complications
intensive care
nursing care
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired.

If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. This study was planned as a randomized controlled experimental study to examine the effect of using an evidence-based protocol on eye care on ophthalmologic complications. Patients who meet the inclusion criteria will be randomized, and one eye of the patients will be assigned to the intervention group (experimental group) and the other to the control group. When the study reaches 40 patients, G\*Power analysis will be applied and the sample size will be decided according to the result.


Eligibility criteria: Inclusion Criteria:

* Patients connected to mechanical ventilator,
* Newly intubated patients,
* Patients who have not been diagnosed with keratopathy and keratoconjunctivitis as of hospitalization,
* Patients who have not been diagnosed with burns and facial injuries,
* Patients without chronic lagophthalmos and eye trauma before ICU admission

Exclusion Criteria:

* Patients who have received topical drug therapy other than ocular lubrication
* Patients with muscle weakness as a result of cranial nerve VII (facial) nerve palsy
* Patients with chronic lagophthalmos and eye infections
* Those with rheumatological diseases
* Those with neurological/neuropathic disease that will affect eye closure

Primary outcomes:
measure: Corneal Changes Rating Scale
timeFrame: the day before the intervention
measure: Corneal Changes Rating Scale
timeFrame: 5th day of application
measure: Corneal Changes Rating Scale
timeFrame: 10th day of application
Secondary outcomes:
measure: Dry Eye Rating Scale
timeFrame: the day before the intervention
measure: Dry Eye Rating Scale
timeFrame: 5th day of application
measure: Dry Eye Rating Scale
timeFrame: 10th day of application
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Hospital
Study officials:
References:
citation: El Hachimi R, El Hadiri R, Benchekroun S, Boutimzine N, Amazouzi A, Cherkaoui LO, Maazouzi AW. [Incidence and risk factors of exposure keratopathy in intensive care units: About 91 patients]. J Fr Ophtalmol. 2022 Dec;45(10):1137-1143. doi: 10.1016/j.jfo.2022.03.009. Epub 2022 Oct 29. French.
citation: Ezra DG, Chan MP, Solebo L, Malik AP, Crane E, Coombes A, Healy M. Randomised trial comparing ocular lubricants and polyacrylamide hydrogel dressings in the prevention of exposure keratopathy in the critically ill. Intensive Care Med. 2009 Mar;35(3):455-61. doi: 10.1007/s00134-008-1284-4. Epub 2008 Sep 23.
citation: Hartford JB, Bian Y, Mathews PM, De Rojas J, Garg A, Rasool N, Schroder SK, Trief D. Prevalence and Risk Factors of Exposure Keratopathy Across Different Intensive Care Units. Cornea. 2019 Sep;38(9):1124-1130. doi: 10.1097/ICO.0000000000001961.
citation: Kousha O, Kousha Z, Paddle J. Exposure keratopathy: Incidence, risk factors and impact of protocolised care on exposure keratopathy in critically ill adults. J Crit Care. 2018 Apr;44:413-418. doi: 10.1016/j.jcrc.2017.11.031. Epub 2017 Nov 28.
citation: Mela EK, Drimtzias EG, Christofidou MK, Filos KS, Anastassiou ED, Gartaganis SP. Ocular surface bacterial colonisation in sedated intensive care unit patients. Anaesth Intensive Care. 2010 Jan;38(1):190-3. doi: 10.1177/0310057X1003800129.