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Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
False alarms may be particularly prevalent in the neonatal intensive care unit (NICU) where uncontrolled motion of infants can intensify the problem. The performance of pulse oximeters is of particular importance in the NICU because of the danger that both hyperoxemia and hypoxemia pose to newborns; hyperoxemia can lead to chronic lung disease or retinopathy of prematurity, and hypoxemia depresses spontaneous ventilation. High false alarm rates contribute to the problem of noise in the NICU. They also have the potential to endanger patients if clinicians become inured to the continual alarms and ignore some that may be clinically relevant. There have been few studies on the utility of pulse oximeter alarms in the NICU, particularly with the new-generation technology. This study will build on the small body of existing literature on alarm rates in new-generation pulse oximeters in neonates and provide details about the relationship of the alarms to clinical interventions.
This is an observational study of 50 infants at three hospitals in the United States. The observer will be an experienced nurse with comprehensive training to ensure consistency. The infants and clinical staff will be observed for four hours continuously. Observers will note the timing of alarms, response, interrupted clinical staff activities, and any clinical interventions, and timing of interventions. Clinical staff will also be questioned on whether the alarm was consistent with a desaturation event. Infant characteristics may affect the frequency of alarms. Data collected will include age, gender, weight, ethnicity, diagnosis, and medications.
This study will evaluate the proportion of nuisance alarms relative to the proportion of clinically relevant alarms. It will also evaluate the differences in alarm frequencies across infant characteristics and characterize nurse activities interrupted by the alarms.
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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neonates in the intensive care unit
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| Name | Affiliation | Role |
|---|---|---|
| Roger Mecca, MD | Medtronic - MITG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Wake Forest University School of Medicine |
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All infants in the neonatal intensive care unit that required continuous pulse oximetry qualified for the study during the dates of January 2010 through April 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants With Oxygen Level Monitoring | In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sat Secs Off--No Alarm Evaluation |
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| 10 Sat Secs--10 Second Alarm Evaluation |
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| 25 Sat Secs--25 Second Alarm Evaluation |
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| 50 Sat Secs--50 Second Alarm Evaluation |
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| 100Sat Secs-100 Second Alarm Evaluation |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants With Oxygen Level Monitoring | In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care. |
| 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 | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant. | All patients with complete data | Posted | Number | percentage of interventions | 4 hours |
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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 | Infants With Oxygen Level Monitoring | In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care. |
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The study oximeter's detection could have been 60 seconds before or after the recorded clinical intervention because of sampling bias. There were many desaturations that led to alarms that had no interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fran Haury, RRT Research Coordinator | Covidien | 303 305-2314 | fran.haury@covidien.com |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 0 |
| 50 |
| 0 |
| 50 |
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