Determination the effect of Eye Care Protocol on the Prevention of Eye Surface Disorders in admitted Patients in ICU
Design
Clinical trial using control and intervention groups and randomized on 70 patients
Settings and conduct
A type of eye care protocol was performed for the patient to determine the incidence of eye complications after using this protocol. Initially, the protocol implementation method was taught to ICU nurses by ophthalmologist and the researcher before the intervention. In the initial examination, the health of cornea in eligible patients was examined using fluorescein staining and schirmer test. The schirmer test was used to check for dry eye
Participants/Inclusion and exclusion criteria
Entry criteria was including the age over 18 years and under 75, level of consciousness less than 8, patients with mechanical ventilation and impaired eyelid reflexes
Intervention groups
.
The study looked at the effect of eye care, including keeping the eye closed with adhesive tape in patients whose eyelids were incompletely closed, as well as keeping the eye moist with 0.3% Hypromellos tear drops on superficial eye disorders. The eye disorders were keratitis, conjunctivitis, corneal ulcers and dry eyes. This care was performed on both eyes of the intervention group and compared with both patients' eyes in the control group.
Main outcome variables
use of eye care protocol reduced the incidence of keratitis, conjunctivitis, dry eye and corneal ulcers in patients admitted to special wards.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190522043671N1
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Fariba Mobarez
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3291 0147
Email address
faribamobarez@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-25, 1398/02/05
Expected recruitment end date
2019-12-27, 1398/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Eye Care Protocol on the Prevention of Eye Surface Disorders in admitted Patients in ICU
Public title
Effect of Eye Care Protocol on the Prevention of Eye Surface Disorders in admitted Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
level of consciousness less than 8,
patients with mechanical ventilation and impaired eyelid reflexes
no history of hospitalization in the intensive care unit for a last month
no history of eye problems (eye diseases)
lack of use the ophthalmic medications such as corticosteroid eye drops
no allergy to eye lubricants
no eye trauma
no symptoms of increased intracranial pressure,
health of the corneal surface in the initial examination
at least 24 hours after the admitted to the intensive care unit
Exclusion criteria:
return of the blinking reflex during the study period
discharge or transfer of the patient from the intensive care unit
death of the patient before the end of the study period.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
35 patients in the group intervention and 35 patients in the group control
Randomization (investigator's opinion)
Randomized
Randomization description
The present study was a semi-experimental intervention study (ethical code number IR.AJUMS.REC.1398.314) . Samples were selected from a research community that had entry criteria. They were assigned into 2 intervention and control groups randomly. Random allocation of the type of intervention to the subjects in the study (nurses) was random and by the method of random blocks with block size 4 (using the table related to random replacements). A random list was prepared by a statistician. The type of intervention was assigned to each person who entered the study, according to a random list and the corresponding codes. Entry criteria was including the age over 18 years and under 75, level of consciousness less than 8, patients with mechanical ventilation and impaired eyelid reflexes, no history of hospitalization in the intensive care unit for a last month, no history of eye problems (eye diseases), lack of use the ophthalmic medications such as corticosteroid eye drops, no allergy to eye lubricants, no eye trauma, no symptoms of increased intracranial pressure, health of the corneal surface in the initial examination and at least 24 hours after the admitted to the intensive care unit. Exit criteria were the return of the blinking reflex during the study period, discharge or transfer of the patient from the intensive care unit, and death of the patient before the end of the study period.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Ahvaz Jundishapur University of Medical Sciences
keratitis , conjunctivitis, eye dryness and corneal ulcer
Timepoint
Before starting the intervention and after the intervention
Method of measurement
schirmer test, use of fluorescein staining and slit lamp manual
Secondary outcomes
1
Description
keratitis , conjunctivitis , eye dryness and corneal ulcer
Timepoint
Befor the intervention,After the intervention
Method of measurement
schirmer test, use of fluorescein staining and slit lamp manual
Intervention groups
1
Description
. For the eye care protocol in eligible hospitalized patients in the ICU: In the first stage, the position of the eyelids was evaluated and according to the position of the eyelids, patients were divided into three groups and appropriate eye care was performed in each group. 1. The first group consisted of patients with closed eyelids. In this group, one drop of Hypromellose 0.3% was applied to both patients' eyes every 2 hours and continued for 4 hours.2. In the second group, conjunctivitis of the eye was only seen. In this group, in addition to using three drops of Hypromellose 0.3% every 2 hours that lasted for 6 hours, the adhesive tape was also used horizontally across the eye to keep the eyes closed (a piece of adhesive was used horizontally on the upper eyelid and another adhesive used under the lower eyelid and on the skin of the face).3. In the third group, the patient's cornea was exposed. These patients are at higher risk. In this group, three drops of Hypromellose 0.3% were applied every 2 hours (for 8 hours), and the adhesive tape was used horizontally throughout the eye to keep the eyes closed.This eye care was performed for 5 days and the ophthalmologist, without knowing the method of eye care, evaluated the patients before and after the intervention using fluorescein staining, schirmer test and slit lamp in terms of superficial eye disorders. The final evaluation was then performed by an ophthalmologist using a portable slit lamp, as well as the nurses' daily notes, ICU charts, and the occurrence of keratitis and conjunctivitis. The presence of white or yellow spots in the cornea was a sign of keratitis, and a red conjunctiva with tearing and swelling of the eyelids, indicated that conjunctivitis would develop. Patients with superficial eye disorders were treated by an ophthalmologist or ICU physician
Category
N/A
2
Description
Control group: all patients in the control group received a routine eye care every 2 hours (including washing the eyelid and surrounding skin using gas and sterile water).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Fariba Mobarez
Street address
No 19, Shahrvand Ave, Bahonar, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
3265822112
Phone
+98 61 3291 0147
Email
faribamobarez@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology Ahwaz Jundishapur University
Street address
No 19, Shahrvand Ave, Bahonar, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
3258523221
Phone
+98 61 3291 0147
Email
faribamobarez@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology Ahwaz Jundishapur University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fariba Mobarez
Position
MSc Student of Intensive care nursing, Student Research Committee, Ahvaz Jundishapur University of M
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 19, Shahrvand Ave, Bahonar, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
3252521125
Phone
+98 61 3291 0147
Email
faribamobarez@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fariba Mobarez
Position
MSc Student of Intensive care nursing, Student Research Committee, Ahvaz Jundishapur University of M
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 19, Shahrvand Ave, Bahonar, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
3252541212
Phone
+98 61 3291 0147
Email
faribamobarez@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fariba Mobarez
Position
MSc Student of Intensive care nursing, Student Research Committee, Ahvaz Jundishapur University of M
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 19, Shahrvand Ave, Bahonar, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
3256524185
Phone
+98 61 3291 0147
Email
faribamobarez@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD