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IRCT20200711048079N1 IRCT 2020-08-01 Shahid Beheshti University of Medical Sciences The Comparison of Three Methods of Eye Care Using Polyethylene Covers, Artificial Tear Gel and Common Method on Prevention of Dry Eye and Corneal Ulcer in Older People Admitted to Intensive Care Units The Comparison of Three Methods of Eye Care Using Polyethylene Covers, Artificial Tear Gel and Common Method on Prevention of Dry Eye and Corneal Ulcer in Older People Admitted to Intensive Care Units 2020-08-22 anticipated 99 Complete https://irct.ir/trial/49563 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the available random sampling method will be used and participants in the study are divided into three groups A, B and C, which group A artificial tear gels in the right eye and in the left eye polyethylene Covers, in Group B, artificial tear gels in the left eye and polyethylene Covers in the right eye and Group C, is the usual method. Intervention methods for random assignment will be placed in dark envelopes and each participant will be assigned an envelope using a random number table. The allocation of the number of study participants to each hospital will be based on the number of annual hospitalizations in the intensive care unit of that center, Blinding description: Due to the patient's condition, which has a decreased level of consciousness, is under mechanical ventilation, and receives sedatives and muscle relaxants, the patient is not aware of the type of intervention, but to any of the participants' legal guardians if they wish to participate in the project, Explanations about the purpose of the research and ensuring the confidentiality of data information and informed consent will be obtained. 3 Condition 1: Dry Eye Syndrome. Condition 2: Corneal Ulcer. Intervention 1: Intervention group: Group A: Artificial tear gels in the right eye every six hours for five days and in the left eye polyethylene coating and its replacement every 12 hours for five days. Intervention 2: Intervention group: Group B: Artificial tear gels in the left eye every six hours for five days and in the right eye polyethylene coating and its replacement every 12 hours for five days. Intervention 3: Intervention group: Group C: Both eyes of the patient are cared for in the usual way, so that both eyes are covered with anti-allergy glue and change the glue every 12 hours for five days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Ali Darvishpoor Kakhki
Department of Internal Surgery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh Highway Intersection, Valiasr St.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 Ali.darvishpoor@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ali Darvishpoor Kakhki
Department of Internal Surgery, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh Highway Intersection, Valiasr St.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 Ali.darvishpoor@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) They are 60 years old or older. Be hospitalized in the intensive care unit. Have a endotracheal tube and be mechanically ventilated. Have a Glasgow coma scale score of seven or below seven. Their body temperature should be between 36.4 to 37.2 in the morning and 37.2 to 37.8 in the evening using an oral thermometer. Do not have dry eyes at the time of admission using the Schirmer test. Do not have corneal ulcers at the time of admission using the Fluorescein test. Blink less than five times per minute. No head and face trauma. Have no signs of increased intracranial pressure. Have no history of using eye lubricants (before hospitalization). Have no history of eye disease or eye surgery. Have no history of hospitalization in the intensive care unit during the past month. Incomplete closing of the eyelids due to the use of sedatives There are no wounds, eye injuries or eye infections 60 years no limit Both Patients whose hospitalization time is more than 24 hours. Patients admitted to the ward with a diagnosis of brain death. Patients whose level of consciousness is increased and they are separated from mechanical ventilation Patients' deaths occur. Patients who are admitted to the intensive care unit for less than five days. Patients who are transferred to other wards during the study. Patients whose blinking reflex returns. Patients who are allergic to artificial tears gel. H04.12 H16.0 Dry eye syndrome Corneal ulcer Prevention Prevention Prevention Intervention group: Group A: Artificial tear gels in the right eye every six hours for five days and in the left eye polyethylene coating and its replacement every 12 hours for five days. Intervention group: Group B: Artificial tear gels in the left eye every six hours for five days and in the right eye polyethylene coating and its replacement every 12 hours for five days. Intervention group: Group C: Both eyes of the patient are cared for in the usual way, so that both eyes are covered with anti-allergy glue and change the glue every 12 hours for five days. Dry eye. Timepoint: The first day of intervention and then daily for five days. Method of measurement: Schirmer Test. Corneal Ulcer. Timepoint: The first day of intervention and then daily for five days. Method of measurement: Fluorescein Test. Shahid Beheshti University of Medical Sciences Approved 2020-07-26 Ethics committee of School of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical School of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niayesh Highway Intersection, Valiasr St. Tehran Tehran Iran (Islamic Republic of)