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Clinical Trials/NCT02256384
NCT02256384
Completed
N/A

Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Children's Hospital Medical Center, Cincinnati2 sites in 1 country76 target enrollmentMarch 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Complications
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
76
Locations
2
Primary Endpoint
Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
Status
Completed
Last Updated
5 years ago

Overview

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 of respiratory rate in postoperative pediatric patients at risk of adverse respiratory events.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
August 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)

Time Frame: Up to 24 hours after surgery

The respiratory acoustic monitor records three vital signs: Respiration rate recorded in breaths per minute, oxygen saturation recorded in percentage, and heart rate recorded in beats per minute. The reliability and accuracy of the respiratory data collected by the RAM was examined by comparing to data collected clinically by the manual counting of the respiratory rate and by the respiratory rate measure by transthoracic impedance . The accuracy of RAM was examined when a staff member goes and register these measurements that occur simultaneously during the first minute of every 2 hour interval to a maximum of a 24 hour monitoring time.

Secondary Outcomes

  • Presence of False Alarms(Up to 24 hours after surgery)
  • Tolerance of the RAM(Up to 24 hours after surgery)

Study Sites (2)

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