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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Eye Injuries Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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plastic wrap over eye & lubrication applied q6 hrs

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Martha AQ Curley, PhD

Role: STUDY_CHAIR

Boston Children's Hospital

Locations

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Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2003-12005

Identifier Type: -

Identifier Source: org_study_id