Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Pediatric Clinical Trial

Official title:

Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256384
• Other study ID #: 2014-6421
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric
• Respiratory Complications

Intervention

Device:
• Respiratory Acoustic Monitor
Examine the reliability and accuracy of the respiratory acoustic monitor.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	UT Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Children's Medical Center Dallas, Masimo Corporation, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)	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.	Up to 24 hours after surgery
Secondary	Presence of False Alarms	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.	Up to 24 hours after surgery
Secondary	Tolerance of the RAM	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.	Up to 24 hours after surgery