Skip to main content
OpenTrials
Completed

NCT Number: NCT02256384

Evaluation of Respiratory Acoustic Monitor in Children After Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Acoustic Monitor

Device

Examine the reliability and accuracy of the respiratory acoustic monitor.

Primary outcomes

  1. 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

  1. Presence of False Alarms

    Time frame: Up to 24 hours after surgery

    To evaluate the presence of false alarms, bedside clinical monitoring was done every two hour during 5 to 15 minutes (random sample) recording the respiratory rates and evaluating the presence of alarms. If an alarm was activated during the bedside monitoring, it was verified by the investigator if the respiratory rate provided by the device was consistent with the clinical evaluation. False alarms were considered those alarms that are triggered by the device, but during simultaneous clinical evaluation it was verified that the number of breaths per minute were inaccurate. Therefore, the higher number of false alarms detected by one type of monitoring indicates that the device is less reliable detecting the respiratory rate.

  2. Tolerance of the RAM

    Time frame: Up to 24 hours after surgery

    The tolerance is defined as the ratio of the time the sensor stays in place divided by the total expected time of monitoring, expressed as a percentage. The tolerance to the transthoracic impedance pads was not evaluated during this study considering that this is the standard monitoring and that is usually tolerated during the total expected time of monitoring.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Children's Medical Center Dallas
  • Masimo Corporation
  • University of Texas Southwestern Medical Center

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2014
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.