NCT Number: NCT00129077
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
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.
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Notify MeKey information
Conditions
Age range
2 week–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Children's Memorial Hospital, Chicago, Illinois, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Development of corneal abrasions
Time frame: 9 days
Secondary outcomes
-
Incidence of corneal abrasions
Time frame: 36 hours
Sponsors and collaborators
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Collaborators
- American Association of Critical Care Nursing
- Boston Children's Hospital
- Society of Critical Care Medicine
Registry information
Important dates
- Study start
- 2004
- Study completion
- 2006
- First posted
- Aug 11, 2005
- Registry last updated
- Jul 10, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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