HypoxemiaNCT01085539
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
An observational study of Hypoxemia, run by Medtronic - MITG at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxemia
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2010to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: neonates in the intensive care unit
Who may be able to join
- Infants in the NICU continuously monitored by pulse oximetry
Who cannot join
- Infants whose legal guardians do not consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
MetroHealth Medical Center
Cleveland, Ohio, 44109
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Oxygen Saturation Monitoring in the Neonatal Intensive Care Unit (NICU): An Observational Study of Response to Alarms
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.
Read the 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.
- Conditions
- Hypoxemia
- Keywords
- neonatal intensive care, infant pulse oximetry
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Mecca, MD, Study chair, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085539
- Sponsor's protocol ID
- COV-M0-PO-A108
- Status last verified
- Aug 2014
- First submitted
- 10 Mar 2010
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Saturation Monitoring in the Neonatal Intensive Care Unit (NICU): An Observational Study of Response to Alarms
- ClinicalTrials.gov ID
- NCT01085539
- Acronym / sponsor ID
- COV-M0-PO-A108
- Conditions
- Hypoxemia
- Keywords
- neonatal intensive care, infant pulse oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- neonates in the intensive care unit
Key inclusion criteria (1 listed)
- Infants in the NICU continuously monitored by pulse oximetry
Key exclusion criteria (1 listed)
- Infants whose legal guardians do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Mecca, MD study chair
Medtronic - MITG
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia, run by Medtronic - MITG at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.