The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
NCT ID: NCT07000565
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2024-11-01
2025-01-01
Brief Summary
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H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients.
H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients.
H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Artificial tears
Every 2 hours, artificial tear solution was gently applied to the designated eye. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation. The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.
Eye Care with Artificial Tears
Every 2 hours, the artificial tear solution was gently applied to the designated eye for 5 days. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation.
Saline
Every 2 hours, saline solution (Bio-Fleks brand) was gently applied to the assigned eye for saline group.The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation.
Eye Care with Normal Saline
Every 2 hours, the saline solution(Bio-Fleks brand) was gently applied to the designated eye for 5 days.
Interventions
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Eye Care with Artificial Tears
Every 2 hours, the artificial tear solution was gently applied to the designated eye for 5 days. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation.
Eye Care with Normal Saline
Every 2 hours, the saline solution(Bio-Fleks brand) was gently applied to the designated eye for 5 days.
Eligibility Criteria
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Inclusion Criteria
* Receiving invasive mechanical ventilation
* Admitted to the pediatric intensive care unit
* Parent(s) or legal guardian(s) provide informed consent for participation
Exclusion Criteria
28 Days
18 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Senanur Şimşek
Principal Investigator
Principal Investigators
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Bilgi Gülseven Karabacak, MSc. PhD.
Role: STUDY_DIRECTOR
Marmara University
Locations
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Istanbul University Istanbul Medical Faculty
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Other Identifiers
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2855458
Identifier Type: -
Identifier Source: org_study_id
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