Clinical trial NCT00129077: Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
Official title: Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Injuries
Critically Ill
Keywords: Pediatric critical care
neuromuscular blocking agents
corneal abrasions
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Society of Critical Care Medicine
name: American Association of Critical Care Nursing
First posted: 2005-08-11
Enrollment: 207
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

Detailed description: Critically ill children may require neuromuscular blockade as a treatment modality. These children require careful eye care to prevent corneal abrasions. However, current evidence does not exist to guide best practices on eye care. This research study will evaluate 2 types of eye care therapy. The eyes will be randomly assigned to the control or experimental eye care therapy group. The control eye will receive lubricating ointment every 6 hours. The experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. Using daily fluorescein staining to detect corneal abrasions, each child will be studied for up to 9 days. Children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. The two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

Eligibility criteria: Inclusion Criteria:

* Age greater than 42 weeks post-conceptual age and less than 18 years
* Anticipated need for neuromuscular blockade therapy for at least 24 hours

Exclusion Criteria:

* Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study)
* Past medical history of abnormal blink reflex or incomplete lid closure
* History of daily eye drop use
* Facial trauma
* Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber
* Known allergy to eye lubricant

Primary outcomes:
measure: Development of corneal abrasions
timeFrame: 9 days
Secondary outcomes:
measure: Incidence of corneal abrasions
timeFrame: 36 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Martha AQ Curley, PhD
role: STUDY_CHAIR
References: