Back to resultsDoes the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
Primary Purpose
Eye Injuries, Critically Ill
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
plastic wrap over eye & lubrication applied q6 hrs
Sponsored by
About this trial
This is an interventional prevention trial for Eye Injuries focused on measuring Pediatric critical care, neuromuscular blocking agents, 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
Sites / Locations
- Children's Memorial Hospital
- Children's Hospital Boston
Outcomes
Primary Outcome Measures
Development of corneal abrasions
Secondary Outcome Measures
Incidence of corneal abrasions
Full Information
NCT ID
NCT00129077
First Posted
August 9, 2005
Last Updated
July 9, 2007
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Boston Children's Hospital, Society of Critical Care Medicine, American Association of Critical Care Nursing
1. Study Identification
Unique Protocol Identification Number
NCT00129077
Brief Title
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
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Boston Children's Hospital, Society of Critical Care Medicine, American Association of Critical Care Nursing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Injuries, Critically Ill
Keywords
Pediatric critical care, neuromuscular blocking agents, corneal abrasions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
plastic wrap over eye & lubrication applied q6 hrs
Primary Outcome Measure Information:
Title
Development of corneal abrasions
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Incidence of corneal abrasions
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha AQ Curley, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
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