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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 (CORNEALPREV)

Primary Purpose

Keratitis, Corneal Ulcer

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LACRIBELL®
LIPOSIC®
Glad wrap
Sponsored by
Hospital Risoleta Tolentino Neves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratitis focused on measuring Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial

Eligibility Criteria

18 Years - 93 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Risoleta Tolentino Neves

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Sham Comparator

Sham Comparator

No Intervention

Arm Label

Eye drop

Ocular gel

Glad wrap

Control group

Arm Description

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

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

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

Ocular cleansing three times a day.

Outcomes

Primary Outcome Measures

Keratitis
Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2014
Last Updated
November 18, 2014
Sponsor
Hospital Risoleta Tolentino Neves
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02293876
Brief Title
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
Acronym
CORNEALPREV
Official Title
Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Risoleta Tolentino Neves
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis, Corneal Ulcer
Keywords
Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye drop
Arm Type
Sham Comparator
Arm Description
Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing.
Arm Title
Ocular gel
Arm Type
Sham Comparator
Arm Description
Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.
Arm Title
Glad wrap
Arm Type
Sham Comparator
Arm Description
Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Ocular cleansing three times a day.
Intervention Type
Device
Intervention Name(s)
LACRIBELL®
Other Intervention Name(s)
Eyedrop
Intervention Description
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
Intervention Type
Device
Intervention Name(s)
LIPOSIC®
Other Intervention Name(s)
Occular Gel
Intervention Description
Carbomer and Sorbitol based gel, used in the treatment of dry eye.
Intervention Type
Device
Intervention Name(s)
Glad wrap
Other Intervention Name(s)
Polyethylene film
Intervention Description
A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.
Primary Outcome Measure Information:
Title
Keratitis
Description
Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.
Time Frame
Five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
93 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreza Werli-Alvarenga, RN, MD, PhD
Organizational Affiliation
Hospital Risoleta Tolentino Neves
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Risoleta Tolentino Neves
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31744012
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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