Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Respiratory Complications Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Respiratory Acoustic Monitoring

All participants will wear the respiratory acoustic monitoring device.

Group Type EXPERIMENTAL

Respiratory Acoustic Monitor

Intervention Type DEVICE

Examine the reliability and accuracy of the respiratory acoustic monitor.

Interventions

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Respiratory Acoustic Monitor

Examine the reliability and accuracy of the respiratory acoustic monitor.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No