Determining the Effect of Implementation of Eye Care Protocol on Occurrence of Superficial Eye Disorders in Patients admitted to Intensive Care Units
Design
Clinical trial
Settings and conduct
Data collection included demographic information and severity of eye surface disorders from day 2 to day 7 in intensive care units
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients admitted to intensive care units with a level of consciousness equal to or less than 8 and requiring mechanical ventilation and corneal surface health at initial examination.
Intervention groups
Intervention group (left eye): Use lubricant in the lower conjunctival sac for 1 hour every 4 hours, close the eye, endotracheal suction on one side of the bed, if there is superficial dry eye, eyelid cleaning every 2 hours, Use lubricant and close your eyes
Control group (right eye): Rinse eyes with sterile gas impregnated with normal saline per shift
Main outcome variables
Superficial eye disorders (dryness and corneal ulcer)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140307016870N5
Registration date:2019-11-13, 1398/08/22
Registration timing:retrospective
Last update:2019-11-13, 1398/08/22
Update count:0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Khadije Nasiriani
Name of organization / entity
Yazd Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1755
Email address
nasiriani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-03-04, 1397/12/13
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-06-21, 1398/03/31
Scientific title
The effect of an eye care protocol on the incidence of ocular surface disorders in patients admitted to intensive care unit.
Public title
Comparison of an the effect of eye care protocol and routine eye care on superficial eye disorders in ICU patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Admitted to intensive care unit
Reduce the level of consciousness to a maximum of 8
Corneal surface health at initial examination
Requires mechanical ventilation and sedation
Exclusion criteria:
Facial and eye trauma in a way that prevents eye care
History of Ocular Problems (Ocular Diseases, Eye Infection, Ocular Trauma, Chronic Lagophthalmos, Ocular Drugs and Allergies)
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
School of Nursing & Midwifery, Buali street, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
00983518241755
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
ir.ssu.medicine.rec.1397.033
Health conditions studied
1
Description of health condition studied
Corneal surface disorders
ICD-10 code
H16.9
ICD-10 code description
Unspecified keratitis
Primary outcomes
1
Description
Dry eye
Timepoint
Daily
Method of measurement
With fluorescein tape, according to a grading system
2
Description
Ocular surface disoeder
Timepoint
Daily
Method of measurement
With fluorescein tape, according to a grading system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Left eye): Eye for risk factors for superficial disorders (decreased blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Was reviewed and recorded daily. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Measures for grade 1 and 2 Lagophthalmos include: Washing hands before and after the procedure, applying lubricant in the inferior conjunctival sac for 1 hour every 4 hours, closing the eye, suctioning the chip on one side of the bed with eyes closed, and if there is an infection Or blinking from time to time. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Measures include: washing hands before and after the procedure, cleaning the eyelids every 4 hours and every 2 hours in the presence of excessive eye discharge or respiratory infection (cleaning the eyelid with gas and swallowing in one direction from the inside out). Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Measures include, hand washing before and after the procedure, eye hygiene cleaning the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the outside), applying lubricant in the lower conjunctival sac 1 cm Every 4 hours or so, the eyes were not closed if there was an infection or blink. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Measures include: Ophthalmologic consultation, Eye hygiene cleaning of the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the inside out), applying lubricant in the lower conjunctival sac for 1 hour every 4 hours and closing the eye. Control group (right eye): Eye for risk factors for superficial disorders (reduction of blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Daily recorded and recorded. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Routine care was performed including washing the eyes with sterile gas impregnated with normal saline every eight hours (once per shift).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital of Yazd
Full name of responsible person
azam pourghaffari lahiji
Street address
Shahid Rahnemoun Hospital, Yazd
City
yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0001
Email
apourghaffarilahiji@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr khadijeh nasiriani
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
yazd
Province
Yazd
Postal code
00983518241755
Phone
+98 35 3824 1751
Email
nasiriani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Yazd University of MedicalSciences
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
Yazd University of Medical Sciences
Full name of responsible person
azam pourghaffari lahiji
Position
Msn In Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd University of Medical Sciences, School of Nursing and Midwifery Yazd
City
yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 6260001
Email
apourghaffarilahiji@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
azam pourghaffari lahiji
Position
Msn In Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0001
Email
apourghaffarilahiji@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
yazd
Province
Yazd
Postal code
00983518241755
Phone
+98 35 1824 1755
Fax
Email
nasiriani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The primary outcome data is shared
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Perform meta-analysis and systematic review
From where data/document is obtainable
Dr khadijeh nasiriani, School of Nursing and Midwifery Yazd؛ In Front of the
Infertility Center؛ Safaieh street؛ Bu Ali Boulevard, postal code: 00983518241755, 00989133593437
What processes are involved for a request to access data/document
Send email to Azam Purghafari Lahiji by email: apourghaffarilahiji@gmail.com