Corneal Lesions in Intensive Care Unit (ICU) Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center

Study Overview
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Brief Summary
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The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.

Detailed Description
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Critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .

Official Title
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Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial

Conditions
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Keratitis, Corneal Ulcer

Intervention / Treatment
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* Device: LACRIBELL®
* Device: LIPOSIC®
* Device: Glad wrap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ramsay sedation scale 5 or 6 Glasgow coma scale lower than 7 Use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation Blink reflex less than 5 times per minute or ocular globe exposure Exclusion Criteria: Less than 48 hours in Intensive Care Unit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 93 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Eye drop<br>Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing. | Device: LACRIBELL®<br>* Hypromellose and dextran based eyedrop, used in the treatment of dry eye.<br>* Other names: Eyedrop;|
| Sham Comparator: Ocular gel<br>Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border. | Device: LIPOSIC®<br>* Carbomer and Sorbitol based gel, used in the treatment of dry eye.<br>* Other names: Occular Gel;|
| Sham Comparator: Glad wrap<br>Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber. | Device: Glad wrap<br>* A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.<br>* Other names: Polyethylene film;|
| No Intervention: Control group<br>Ocular cleansing three times a day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratitis | Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop. | Five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial