CORNEALPREV: 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

Sponsor

Hospital Risoleta Tolentino Neves (Other)

Overall Status

Completed

CT.gov ID

NCT02293876

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Fundação de Amparo à Pesquisa do estado de Minas Gerais (Other)

360

Enrollment

Location

Arms

Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keratitis Corneal Ulcer	Device: LACRIBELL® Device: LIPOSIC® Device: Glad wrap	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Keratitis [Five days]
Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 93 Years

Sexes Eligible for Study:

All

Accepts 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