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Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085539
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : September 5, 2012
Last Update Posted : August 7, 2014
Information provided by (Responsible Party):
Medtronic - MITG

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oxygen Saturation Monitoring in the Neonatal Intensive Care Unit (NICU): An Observational Study of Response to Alarms
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Primary Outcome Measures :
  1. Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
neonates in the intensive care unit

Inclusion Criteria:

  • Infants in the NICU continuously monitored by pulse oximetry

Exclusion Criteria:

  • Infants whose legal guardians do not consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085539

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Medtronic - MITG
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Study Chair: Roger Mecca, MD Medtronic - MITG
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Responsible Party: Medtronic - MITG Identifier: NCT01085539    
Other Study ID Numbers: COV-M0-PO-A108
First Posted: March 12, 2010    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by Medtronic - MITG:
neonatal intensive care
infant pulse oximetry
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Signs and Symptoms