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

Corneal Ulcer Clinical Trial

— CORNEALPREV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293876
• Other study ID #: ICU CORNEAL ULCER 01
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: November 18, 2014
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Hospital Risoleta Tolentino Neves
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 93 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Corneal Ulcer
• Keratitis

Intervention

Device:
• LACRIBELL®
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
• LIPOSIC®
Carbomer and Sorbitol based gel, used in the treatment of dry eye.
• Glad wrap
A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.

Locations

Country	Name	City	State
Brazil	Hospital Risoleta Tolentino Neves	Belo Horizonte	Minas Gerais

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Risoleta Tolentino Neves	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratitis	Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.	Five days	Yes