Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT01085539
• Recruitment Status: Completed
• First Posted: March 12, 2010
• Results First Posted: September 5, 2012
• Last Update Posted: August 7, 2014
• Sponsor: Medtronic - MITG
• Information provided by (Responsible Party): Medtronic - MITG

Study Description

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
Hypoxemia

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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

Criteria

Inclusion Criteria:

• Infants in the NICU continuously monitored by pulse oximetry

Exclusion Criteria:

• Infants whose legal guardians do not consent

Contacts and Locations

Locations

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

Investigators

• Study Chair: Roger Mecca, MD; Medtronic - MITG

More Information

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01085539
• Other Study ID Numbers: COV-M0-PO-A108
• First Posted: March 12, 2010
• 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:

Hypoxia; Signs and Symptoms, Respiratory