Comparing the effectiveness of simple eye ointment with moisture chamber over the eye and eyelid taping to prevent ocular surface disorders in critically ill patients
Unconscious intensive care unit (ICU) patients who are sedated and paralyzed will have inhibited eye protective mechanisms, subjecting them to increased risk of ocular surface disorder (OSD). OSDs can lead to serious eye complications such as corneal perforation, corneal scarring, or long-term visual deficits. Therefore the aim of this study is to compare the effectiveness of simple eye ointment with moisture chamber over the eye (polyethylene wrap) and eyelid taping to prevent OSDs in critically ill patients. In this study, the eligible patients after an initial examination and rejection of OSDs, randomly allocated into one of three groups of methods are available and each patient's eyes are also randomly receive one of the eye cares. There are three groups in this study that they include, group one: each patient receives both simple eye ointment and tape on eyelid which are allocated at random to either the left or right eye, grope two: each patient receives both simple eye ointment and polyethylene cover which are allocated at random to either the left or right eye and group three: each patient receives both simple eye ointment and tape on eyelid which are allocated at random to either the left or right eye. In addition, all participants receive a standard eye-cleansing regime using sterile water and gauze 6 hourly to cleanse the eyelids and surrounding skin. Sample's eyes in terms of incidence and severity of OSDs and severity of chemosis are examined on a daily basis and with a portable slit lamp, according to a grading system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109225426N3
Registration date:2011-10-24, 1390/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-24, 1390/08/02
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Medical University Research Center
Expected recruitment start date
2011-09-20, 1390/06/29
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of simple eye ointment with moisture chamber over the eye and eyelid taping to prevent ocular surface disorders in critically ill patients
Public title
Comparing the effectiveness of simple eye ointment with moisture chamber over the eye and eyelid taping to prevent ocular surface disorders in critically ill patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the unconscious patient that had no blink reflex; age over 18 years; patients without orbital or ocular injury; patients that have not a previous admission to ICU within a month of enrolment; Patients without a pre-existing eye condition (history of trauma, eye disease or infection, chronic lagopthalmos, irregular blinking, received eye-care treatment and allergy to eye lubricant), Informed consent for recruitment provide by the patient’s immediate relatives
Exclusion criteria: positive fluorescein stain at the initial eye assessment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
clinical trail
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Research Center Ethics Committee
Street address
Jahad street, Kerman University of Medical Sciences Research Center
City
Kerman
Postal code
Approval date
2011-09-19, 1390/06/28
Ethics committee reference number
k/90/275
Health conditions studied
1
Description of health condition studied
Corneal surface disorders
ICD-10 code
H16.9
ICD-10 code description
Keratitis, unspecified
2
Description of health condition studied
Chemosis
ICD-10 code
H11.4
ICD-10 code description
) Other conjunctival vascular disorders and cysts,(oedema)
Primary outcomes
1
Description
Ocular surface disoeder
Timepoint
At baseline and then sample's eyes in terms of incidence and severity of ocular surfac disorders are examined on a daily basis to 7 day after initiate of eye care
Method of measurement
With a portable slit lamp, according to a grading system
Secondary outcomes
1
Description
Chemosis
Timepoint
At baseline and then sample's eyes in terms of incidence and severity of chemosis are examined on a daily basis to 7 day after initiate of eye care
Method of measurement
With a portable slit lamp, according to a grading system
Intervention groups
1
Description
- The simple eye ointment are apply into the pocket between eyeball and the lower lid of patient eye every 6h, by the patient' nurse.
Category
Prevention
2
Description
- The patient' eye receives a piece of polyethylene cover tailors to cover the eye from the eyebrow to the cheekbone. The polyethylene cover adheres to patient’s face snugly to form a closed moisture chamber. Adhesive tape was used to secure the edges of the polyethylene cover from seam. The polyethylene cover are changes every 6h.
Category
Prevention
3
Description
- The patient eye are close with tow piece of tape, one on the upper eyelid and one on the lower eyelid. The tapes change every 6h.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU ward, Shahid Bahonar hospital
Full name of responsible person
Mehdi Ahmadinejad
Street address
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences Research Center
Full name of responsible person
Dr. Malekpour Afshar
Street address
Kerman University of Medical Sciences Research Center
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadi nejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0100
Email
mehdia50@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadinejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0100
Email
mehdia50@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadinejad
Position
Assistant professor
Other areas of specialty/work
Street address
ICU ward, Shahid Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
+98 34 1226 0200
Email
mehdia50@ gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)