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IRCT20190522043671N1 IRCT 2020-10-18 Ahvaz University of Medical Sciences Effect of Eye Care Protocol on the Prevention of Eye Surface Disorders in admitted Patients Effect of Eye Care Protocol on the Prevention of Eye Surface Disorders in admitted Patients in ICU 2019-04-25 anticipated 70 Complete https://irct.ir/trial/50431 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A keratitis, conjunctivitis , eye dryness ŘŚcorneal ulcer. Intervention 1: . 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. Intervention 2: 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). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Fariba Mobarez
No 19, Shahrvand Ave, Bahonar, Ahwaz
Ahwaz Iran (Islamic Republic of) 3252521125 +98 61 3291 0147 faribamobarez@gmail.com Ahvaz University of Medical Sciences scientific Fariba Mobarez
No 19, Shahrvand Ave, Bahonar, Ahwaz
Ahwaz Iran (Islamic Republic of) 3252541212 +98 61 3291 0147 faribamobarez@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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. N/A Treatment - Other . 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 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). 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. 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. Deputy of Research and Technology Ahwaz Jundishapur University Approved 2019-04-14 Ethics committee Ahvaz Jundishapur University of Medical Sciences No19,shahrvand Ave,Bahonar,Ahwaz Ahwaz Khouzestan Iran (Islamic Republic of)