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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

NCT ID: NCT02293876

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-11-30

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 .

Conditions

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Keratitis Corneal Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Eye drop

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

Group Type SHAM_COMPARATOR

LACRIBELL®

Intervention Type DEVICE

Hypromellose and dextran based eyedrop, used in the treatment of dry eye.

Ocular gel

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

Group Type SHAM_COMPARATOR

LIPOSIC®

Intervention Type DEVICE

Carbomer and Sorbitol based gel, used in the treatment of dry eye.

Glad wrap

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

Group Type SHAM_COMPARATOR

Glad wrap

Intervention Type DEVICE

A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.

Control group

Ocular cleansing three times a day.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LACRIBELL®

Hypromellose and dextran based eyedrop, used in the treatment of dry eye.

Intervention Type DEVICE

LIPOSIC®

Carbomer and Sorbitol based gel, used in the treatment of dry eye.

Intervention Type DEVICE

Glad wrap

A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.

Intervention Type DEVICE

Other Intervention Names

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Eyedrop Occular Gel Polyethylene film

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

93 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Hospital Risoleta Tolentino Neves

OTHER

Sponsor Role lead

Responsible Party

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Andreza Werli Alvarenga

RN, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreza Werli-Alvarenga, RN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Risoleta Tolentino Neves

Locations

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Hospital Risoleta Tolentino Neves

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ICU CORNEAL ULCER 01

Identifier Type: -

Identifier Source: org_study_id