N/A
N=76
Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Respiratory Complications · Pediatric
Bottom Line
View on ClinicalTrials.gov: NCT02256384 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) — 19.7; 19.6; 21.3 Breaths per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Respiratory Acoustic Monitor (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) |
19.7; 19.6; 21.3 | — |
| SECONDARY Presence of False Alarms |
0.18; 1.00 | — |
| SECONDARY Tolerance of the RAM |
87 | — |
Summary
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02256384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.