Pediatric, Respiratory Complications
Conditions
Keywords
Respiration Rate, Respiratory Acoustic Monitor, postoperative
Brief summary
The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
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.
Interventions
DEVICERespiratory Acoustic Monitor
Examine the reliability and accuracy of the respiratory acoustic monitor.
Sponsors
Masimo Corporation
Children's Medical Center Dallas
University of Texas Southwestern Medical Center
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment not capturing data | 2 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Respiratory Acoustic Monitoring |
|---|---|
| Age, Categorical <=18 years | 62 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiratory Acoustic Monitoring | Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) | 19.7 Breaths per minute | Standard Error 0.52 |
| Manual Counting | Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) | 19.6 Breaths per minute | Standard Error 0.56 |
| Transthoracic Impedance | Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM) | 21.3 Breaths per minute | Standard Error 0.77 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiratory Acoustic Monitoring | Presence of False Alarms | 0.18 Number of false alarms per patient | Standard Deviation 0.71 |
| Manual Counting | Presence of False Alarms | 1.00 Number of false alarms per patient | Standard Deviation 2.78 |
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.
Time frame: Up to 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Respiratory Acoustic Monitoring | Tolerance of the RAM | 87 percentage of time sensor stays in place | Standard Error 4.26 |