The effect of "Balanced Salt Solution" on dry eye will be evaluated in hospitalized patients in intensive care units
Design
40 anesthetized patients admitted to the intensive care unit will be selected according inclusion criteria and using non-probability sampling .One eye will be cared as intervention group (BSS care) and the other eye as control (artificial tear care) .For randomization,coin toss will be used to allocate each eye to two treatments(simple random allocation).One eye assigned to the intervention group and the other to the control group
Settings and conduct
This study will be performed on patients admitted to intensive care unit of Shohada-ye Ashayer Hospital of Khorramabad.The artificial tear control group and the intervention group will receive a formulated eye care program (BSS)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients 18-75 years;Over 24 h on ventilator and GCS of less than 10 and no blinking reaction;No trauma to the face and eyes;Stay in ICU ward for at least 5 days;Not having a known history of ophthalmic disease;and ophthalmic surgery in the last 6 months.Exclusion criteria:Discharge from ICU; Death; Corneal reflex return and GCS score of 10 and above; Hospital stay less than 5 day
Intervention groups
At the beginning of the study,Schirmer test and Tear Breakup Time (TBUT) will be performed.Then each patient's eyes will be cared for 5 days using one of the eye solutions (BSS and artificial tears).Care protocol in control group including hand washing before eye care and use of artificial tears every 6 hours (2 drops) also, sterile eye ointment and adhesive tape will be used on the eyes.In the intervention group, in Addition to the routine care protocol (hand washing, eye ointment and adhesive tape), BSS drops will be used every 6 hours (2 drops) for the patient's eye
Main outcome variables
Dry eye
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200113046121N1
Registration date:2020-02-18, 1398/11/29
Registration timing:registered_while_recruiting
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
parastou kordestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3323 3040
Email address
kordestani.p@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Balanced Salt Solution on Dry eye in Hospitalized Comatose Patients in Intensive care units
Public title
Effect of Balanced Salt Solution on Dry eye
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to the ICU ward with supportive mechanical ventilation admitted within the first 24 hours
18-75 years old
No known history of ophthalmic,Liver, Diabetes, Thyroid And Ocular surgery in the last 6 months
No history of systemic disease such as Sjogren's syndrome, progressive Sclerosis, Sarcoidosis, Leukemia, Lymphoma
At baseline GCS study <10
Patients whose cause is not facial and eye trauma.
Patients who have been in the ICU ward for at least 5 days
Exclusion criteria:
Patients with a hospital Stay of less than 5 days for any reason (Death, Discharge, Transfer)
If the patient's GCS reaches above 10 within the first three days of admission
Patients with altered consciousness may cause blinking on their own
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups: Coin toss will be used to allocate each eye to two treatments (simple random allocation), with one eye assigned to the case group and the other to the control group
Blinding (investigator's opinion)
Triple blinded
Blinding description
Clinical care nurses will not be aware of the type of solution used (label A, B will be available on both solutions)
The optometrist will be unaware of the type of care
The data analyzer will also be unaware of the type of care
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
khorramabad
Province
Lorestan
Postal code
381351698
Approval date
2019-04-15, 1398/01/26
Ethics committee reference number
IR.LUMS.REC.1398.025
Health conditions studied
1
Description of health condition studied
dry eye
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dry eye severity
Timepoint
The first day of hospitalization and the fifth day
Method of measurement
1-Schirmer test 2-Tear Breakup Time with cobalt blue light filter ophtalmoscop
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:1-Schimmer test and TBUT for Dry eye examination before intervention by an optometrist 2-Wash hands before eye care 3-Applying a Balanced Salt Solution every 6 hours (2 drops) will also be followed by sterile eye ointment and adhesive tape on the eye
Category
Prevention
2
Description
Control group: 1-Schimmer test and TBUT for Dry eye examination before intervention by an optometrist 2-Wash hands before eye care 3-Applying a artificial tears every 6 hours (2 drops) will also be followed by sterile eye ointment and adhesive tape on the eye
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Ashayer Khorramabd Hospital
Full name of responsible person
Hengameh Sadeghi Hasanvand
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6297228683
Phone
+98 66 3323 3040
Email
Hengamehsadehi8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0172
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
student
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hengameh Sadeghi Hasanvand
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
khorramabad
Province
Lorestan
Postal code
6297228683
Phone
+98 66 3323 3040
Email
hengamehsadeghi8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Parastou Kordestani Moghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
khorramabad
Province
Lorestan
Postal code
6297228683
Phone
+98 66 3323 3040
Email
kordestani.p@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hengameh Sadeghi Hasanvand
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6297228683
Phone
+98 66 3323 3040
Email
hengamehsadeghi8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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