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 (CORNEALPREV)

Hospital Risoleta Tolentino Neves

Status: Completed

Conditions: Corneal Ulcer; Keratitis

Treatments: Device: Glad wrap; Device: LIPOSIC®; Device: LACRIBELL®

Study type: Interventional

Funder types: Other

Identifiers

NCT02293876

ICU CORNEAL ULCER 01

Details and patient eligibility

About

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

Full description

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 .

Enrollment: 360 patients

Sex: All

Ages: 18 to 93 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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360 participants in 4 patient groups

Eye drop

Sham Comparator group

Description:

Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing.

Treatment:

Device: LACRIBELL®

Ocular gel

Sham Comparator group

Description:

Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.

Treatment:

Device: LIPOSIC®

Glad wrap

Sham Comparator group

Description:

Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.

Treatment:

Device: Glad wrap

Control group

No Intervention group

Description:

Ocular cleansing three times a day.