Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Respiratory Complications; Pediatric

Treatments: Device: Respiratory Acoustic Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02256384

2014-6421

Details and patient eligibility

About

The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Respiratory Acoustic Monitoring

Experimental group

Description:

All participants will wear the respiratory acoustic monitoring device.

Treatment:

Device: Respiratory Acoustic Monitor