Hypoxemia
Conditions
Keywords
neonatal intensive care, infant pulse oximetry
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Infants in the NICU continuously monitored by pulse oximetry
Exclusion criteria
* Infants whose legal guardians do not consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | 4 hours | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Infants With Oxygen Level Monitoring |
|---|---|
| Age, Categorical <=18 years | 50 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 0.73 years STANDARD_DEVIATION 0.02 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 4 hours
Population: All patients with complete data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants With Oxygen Level Monitoring | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs Off | 39.9 percentage of interventions |
| Infants With Oxygen Level Monitoring | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs 10 | 44.4 percentage of interventions |
| Infants With Oxygen Level Monitoring | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs 25 | 48.0 percentage of interventions |
| Infants With Oxygen Level Monitoring | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs 50 | 50.3 percentage of interventions |
| Infants With Oxygen Level Monitoring | Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. | Sat Secs 100 | 53.2 percentage of interventions |