Evaluation of Respiratory Acoustic Monitor in Children After Surgery

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02256384
• Collaborator: Masimo Corporation (Industry), Children's Medical Center Dallas (Other), University of Texas Southwestern Medical Center (Other)
• Enrollment: 76
• Locations: 2
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site: 38
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Complications; Pediatric	Device: Respiratory Acoustic Monitor	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Respiratory Acoustic Monitor in Children After Surgery
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Respiratory Acoustic Monitoring All participants will wear the respiratory acoustic monitoring device.	Device: Respiratory Acoustic Monitor; Examine the reliability and accuracy of the respiratory acoustic monitor.

Outcome Measures

Primary Outcome Measures

1. Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) [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 Outcome Measures

1. Presence of False Alarms [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
2	UT Southwestern Medical Center - Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Mario Patino, MD, Children's Hospital Medical Center, Cincinnati
• Principal Investigator: Peter Szmuk, MD, UT Southwestern Medical Center- Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02256384
• Other Study ID Numbers: 2014-6421
• First Posted: Oct 3, 2014
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Children's Hospital Medical Center, Cincinnati: Respiration Rate; Respiratory Acoustic Monitor; postoperative

Study Results

Participant Flow

Recruitment Details	Whenever possible, the family will be approached at a pre-surgical clinic visit or contacted by phone the day before recruitment to explain the study. Consent will occur in person at either a clinic visit prior to the day of surgery, in the pre-operative area on the day of surgery, or in the patient's room after surgery.

Arm/Group Title	Respiratory Acoustic Monitoring
Arm/Group Description	All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Period Title: Overall Study
STARTED	76
COMPLETED	62
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Respiratory Acoustic Monitoring
Arm/Group Description	All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Overall Participants	62
Age (Count of Participants)
<=18 years	62 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	29 46.8%
Male	33 53.2%

Outcome Measures

1. Primary Outcome

Title	Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
Description	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.
Time Frame	Up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

62 children from 2 to 16 years old that required postoperatory admission for continuous respiratory monitoring.The respiratory rate was measured and recorded at the same time every 2 hours from the: (a) RAM monitor, (b) thoracic impedance, and (c) manual count over 1 minute. In addition the presence of alarms was also recorded.

Arm/Group Title	Respiratory Acoustic Monitoring	Manual Counting	Transthoracic Impedance
Arm/Group Description	All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.	Respiratory rate was recorded by clinical evaluation every 2 hours during the first minute of the evaluation and recorded also simultaneously by RAM and by transthoracic impedance.	The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.
Measure Participants	62	62	62
Mean (Standard Error) [Breaths per minute]	19.7 (0.52)	19.6 (0.56)	21.3 (0.77)

2. Secondary Outcome

Title	Presence of False Alarms
Description	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.
Time Frame	Up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

The presence of alarms and their evaluation as true or false was recorded during 5 to 15 minutes of a fixed interval of every 2 hours.

Arm/Group Title	Respiratory Acoustic Monitoring	Transthoracic Impedance
Arm/Group Description	All participants wore the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.	All participants wore continuous electrocardiographic monitoring capable of recording respiratory rate continuously and the alarm was set up by defaulted respiratory alarms already selected during the regular clinical practice.
Measure Participants	62	62
Mean (Standard Deviation) [Number of false alarms per patient]	0.18 (0.71)	1.00 (2.78)

3. Secondary Outcome

Title	Tolerance of the RAM
Description	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.
Time Frame	Up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Respiratory Acoustic Monitoring
Arm/Group Description	All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Measure Participants	62
Mean (Standard Error) [percentage of time sensor stays in place]	87 (4.26)

Adverse Events

Adverse Event Reporting Description	No serious adverse events were reported related to wearing the monitor sensors. Information regarding skin irritation due to the placement of the sensor was collected just by one of the institutions involved in the study, but was not recorded by the other institution. The total number of participants recruited at the institution that reports the incidence of skin irritation were 30 participants.
Arm/Group Title	Respiratory Acoustic Monitoring
Arm/Group Description	All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
All Cause Mortality
	Respiratory Acoustic Monitoring
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Respiratory Acoustic Monitoring
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Other (Not Including Serious) Adverse Events
	Respiratory Acoustic Monitoring
	Affected / at Risk (%)	# Events
Total	4/30 (13.3%)
Skin and subcutaneous tissue disorders
Skin irritation	4/30 (13.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.