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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129077
• Other study ID #: 2003-12005
• Status: Completed
• Phase: N/A
• First received: August 9, 2005
• Last updated: July 9, 2007
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2007
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Eye Injuries

Intervention

Procedure:
• plastic wrap over eye & lubrication applied q6 hrs

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	Children's Hospital Boston, SePA Chapter of the American Association of Critical Care Nurses, Society of Critical Care Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of corneal abrasions		9 days
Secondary	Incidence of corneal abrasions		36 hours