Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
ICU Therma and General Divisions of Ninth Day Hospital and Razi Hospital of Torbat Heydariyeh
Interventions include the use of polyurethane coating or right eyelid massage in the left eye in both control groups.
Participants/Inclusion and exclusion criteria
Admitted to the intensive care unit,
Score less than 8 according to Glasgow criteria,
Lack of history of liver, diabetes, thyroid and ocular diseases,
Negative Fluorescein and schirmere test at admission,
Absence of eye trauma.
Intervention groups
1 Polyurethane coating on right eye of group I
2 Inactive Movement on Right Eye of Group II
3 The left eyes are both control groups
Comparison the Effect of Polyurethane cover and eyelid massage on the Prevention of Keratopathy in Intensive Care Unit Patients
Public title
Effect of polyurethane coating on corneal scratch prevention, effect of inactive lid movement on corneal scratch prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the intensive care unit
Conscientiousness score less than 8 according to Glasgow criteria
No history of liver, diabetes, thyroid and ocular diseases
Age 15-15 years
Absence of eye trauma
Negative Schirmer and Fluorescein test at admission
Exclusion criteria:
1.Eye trauma while studying
Relapse reflex of blinking patient
Patient discharge before intervention
Unwillingness of the patient's family to continue the study
The current clinical conditions that limit the intervention
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
The patient's right eye is in the intervention group and his left eye is in the control group
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
2
The patient's right eye is in the intervention group and his left eye is in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample was selected based on the inclusion criteria and then randomly assigned to two groups of polyurethane coating and passive eyelid motion using random number table. Six possible modes (BBAA, AABB, ABAB, BABA, ABBA, BAAB) are listed and randomly the number of blocks required is specified and the clients are ranked accordingly.They were divided into two groups: polyurethane coating (A) and inactive lid movement (B). In each group, right eye was considered as intervention and left eye as control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients have decreased consciousness.
The outcome assessor (eye specialist) is not aware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی گناباد
Street address
mansoorieh 9 AVE
City
تربت حیدریه
Province
Razavi Khorasan
Postal code
9518954746
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.GMU.REC.1398.052
Health conditions studied
1
Description of health condition studied
exposure keratopathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blink Disorder
Timepoint
daily
Method of measurement
Observation and examination
Secondary outcomes
1
Description
Scratches and corneal ulcers
Timepoint
daily
Method of measurement
Fluorescein testing and use of cobalt blue light
Intervention groups
1
Description
Intervention group : Using polyurethane coating Askinaderm: In this study, polyurethane coating is used to create a moist chamber on the eye that restricts tear evaporation. Its dimensions range from eyebrows to cheek bumps and from the nasal bridge to one centimeter beyond the outer corner of the eye in such a way that it turns the eye rim into a closed chamber. This cover is replaced daily.
Category
Prevention
2
Description
Intervention group: Massage the eyelids: Passive movement of the eyelid, massage the eyelid, or moving the eyelid gently from the root to its periphery, or the gentle pressure of the eyelids up or down, and the lateral movement from the inner corner of the eye to the outer corner. Passive movement of the patient's eyelids is performed by the nurse three times a day for 5 minutes.
Category
Prevention
3
Description
Control group: Routine care: Rinse with normal saline and close with regular glue
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان های رازی و نهم دی
Full name of responsible person
فهیمه مسعودی
Street address
mansoorieh 9 AVE
City
Torbat e heydarieh
Province
Razavi Khorasan
Postal code
9518954746
Phone
+98 51 5231 7001
Email
farimehrmasoudi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
moosa Sajjadi
Street address
Beginning of the Qaen Belt Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 5813
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
40
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
Gonabad University of Medical Sciences
Full name of responsible person
FAHIMEH MASOUDI
Position
NURSE
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
MANSOORIEH 9
City
TORBAT E HEYDARIEH
Province
Razavi Khorasan
Postal code
9518954746
Phone
+98 51 5231 7001
Email
farimehrmasoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fahimeh Masoudi
Position
Head nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mansoorieh 9 Ave
City
Torbat e heydarieh
Province
Razavi Khorasan
Postal code
9518954746
Phone
+98 51 5231 7001
Email
farimehrmasoudi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fahimeh masoudi
Position
Head Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mansoorieh 9 Ave
City
Torbat e heydarieh
Province
Razavi Khorasan
Postal code
9518954746
Phone
+98 51 5231 7001
Email
farimehrmasoudi@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