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| Name | Class |
|---|---|
| Masimo Corporation | INDUSTRY |
| Children's Medical Center Dallas | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
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The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Acoustic Monitoring | Experimental | All participants will wear the respiratory acoustic monitoring device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Acoustic Monitor | Device | Examine the reliability and accuracy of the respiratory acoustic monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Patino, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Peter Szmuk, MD | UT Southwestern Medical Center- Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| UT Southwestern Medical Center - Dallas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28448390 | Result | 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 Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Breaths per minute | Up to 24 hours after surgery |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Participants complained of their skin being irritated by the adhesive that is used on the sensors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mario Patino | Cincinnati Children's Hospital Medical Center | 513-636-4200 | mario.patino@cchmc.org |
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| Up to 24 hours after surgery |
| 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 |
| Dallas |
| Texas |
| 75235 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | Transthoracic Impedance | The respiratory rate was measured by Transthoracic impedance with the use of the electrocardiogram pads. |
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| 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. | 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. | Posted | Mean | Standard Deviation | Number of false alarms per patient | Up to 24 hours after surgery |
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| 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. | Posted | Mean | Standard Error | percentage of time sensor stays in place | Up to 24 hours after surgery |
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| 0 |
| 62 |
| 4 |
| 30 |
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