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)

November 18, 2014 updated by: Andreza Werli Alvarenga, Hospital Risoleta Tolentino Neves

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 31744012
        • Hospital Risoleta Tolentino Neves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Risoleta Tolentino Neves

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do estado de Minas Gerais

Investigators

  • Principal Investigator: Andreza Werli-Alvarenga, RN, MD, PhD, Hospital Risoleta Tolentino Neves

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU CORNEAL ULCER 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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