Clinical trial NCT02767258: Effect of Nursing Care on Prevention of Dry Eye
Official title: Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Diseases of the eye and adnexa
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: State University of Montes Claros
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-05-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.

Detailed description: Critically ill patients are at higher risk for dry eye 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. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years;
* Did not present dry eye at the time of admission;
* Stay in the ICU for at least 24 hours;
* Be in mechanical ventilation therapy;
* Glance less than 5 per minute;
* Comatose, sedated or Glasgow less than or equal to 7;
* Consent to participate in research or have.

Exclusion Criteria:

* Have not the responsabille authorization;
* Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.

Primary outcomes:
measure: Dry Eye
timeFrame: Five consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Montes Claros
country: Brazil
facility: Santa de Misericórdia Montes Claros
state: Minas Gerais
Study officials:
affiliation: State University of Montes Claros, Minas Gerais, Brazil
name: Diego D Araújo, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17.