Status:
COMPLETED
Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Masimo Corporation
Children's Medical Center Dallas
Conditions:
Respiratory Complications
Pediatric
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief Summary
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
Detailed Description
The study seeks to determine the reliability and accuracy of the acoustic respiratory monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring (TI) and manual counting...
Eligibility Criteria
Inclusion
- Male or female children 2 to 16 years of age
- In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
- Child weighs at least 10 kg on day of surgery
Exclusion
- Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
- Patient is admitted to the Intensive Care Unit
- Patient has tracheostomy
- Patient is on non-invasive ventilator support
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02256384
Start Date
March 1 2015
End Date
August 1 2015
Last Update
October 19 2020
Active Locations (2)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
UT Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75235