Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?

Not Applicable

Completed

• Conditions: Eye Injuries; Critically Ill

• Registration Number: NCT00129077
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-08-09
• Study First Submitted QC: 2005-08-09
• Study First Posted: 2005-08-11
• Study Completion: 2006-12
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-09
• Last Update Posted: 2007-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Development of corneal abrasions	9 days

Secondary Outcome Measures

Name	Time	Method
Incidence of corneal abrasions	36 hours

Trial Locations

Locations (2)

Children's Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States