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

Not Applicable

Completed

• Conditions: Corneal Ulcer; Keratitis
• Interventions: Device: Glad wrap; Device: LACRIBELL®; Device: LIPOSIC®

• Registration Number: NCT02293876
• Lead Sponsor: Hospital Risoleta Tolentino Neves

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-04
• Status Verified: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Glad wrap	Glad wrap	Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.
Eye drop	LACRIBELL®	Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing.
Ocular gel	LIPOSIC®	Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.

Primary Outcome Measures

Name	Time	Method
Keratitis	Five days	Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

Trial Locations

Locations (1)

Hospital Risoleta Tolentino Neves; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil