Trial Outcomes & Findings for Evaluation of Respiratory Acoustic Monitor in Children After Surgery (NCT NCT02256384)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

Up to 24 hours after surgery

Results posted on

2020-10-19

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Respiratory Acoustic Monitoring All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Overall Study STARTED	76
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Respiratory Acoustic Monitoring All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Overall Study Withdrawal by Subject	12
Overall Study Equipment not capturing data	2

Baseline Characteristics

Evaluation of Respiratory Acoustic Monitor in Children After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Respiratory Acoustic Monitoring n=62 Participants All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Age, Categorical <=18 years	62 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours after surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Respiratory Acoustic Monitoring n=62 Participants All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.	Manual Counting n=62 Participants 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.	Transthoracic Impedance n=62 Participants The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.
Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)	19.7 Breaths per minute Standard Error 0.52	19.6 Breaths per minute Standard Error 0.56	21.3 Breaths per minute Standard Error 0.77

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Respiratory Acoustic Monitoring n=62 Participants All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.	Manual Counting n=62 Participants 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.	Transthoracic Impedance The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.
Presence of False Alarms	0.18 Number of false alarms per patient Standard Deviation 0.71	1.00 Number of false alarms per patient Standard Deviation 2.78	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Respiratory Acoustic Monitoring n=62 Participants All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.	Manual Counting 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.	Transthoracic Impedance The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads.
Tolerance of the RAM	87 percentage of time sensor stays in place Standard Error 4.26	—	—

Adverse Events

Respiratory Acoustic Monitoring

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Respiratory Acoustic Monitoring n=30 participants at risk；n=62 participants at risk All participants will wear the respiratory acoustic monitoring device. Respiratory Acoustic Monitor: Examine the reliability and accuracy of the respiratory acoustic monitor.
Skin and subcutaneous tissue disorders Skin irritation	13.3% 4/30 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.

Additional Information

Mario Patino

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place