Trial Outcomes & Findings for Oxygen Saturation Alarms in the Neonatal Intensive Care Unit (NCT NCT01085539)

Last Updated: 2014-08-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

4 hours

Results posted on

2014-08-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Sat Secs Off--No Alarm Evaluation STARTED	50
Sat Secs Off--No Alarm Evaluation COMPLETED	50
Sat Secs Off--No Alarm Evaluation NOT COMPLETED	0
10 Sat Secs--10 Second Alarm Evaluation STARTED	50
10 Sat Secs--10 Second Alarm Evaluation COMPLETED	50
10 Sat Secs--10 Second Alarm Evaluation NOT COMPLETED	0
25 Sat Secs--25 Second Alarm Evaluation STARTED	50
25 Sat Secs--25 Second Alarm Evaluation COMPLETED	50
25 Sat Secs--25 Second Alarm Evaluation NOT COMPLETED	0
50 Sat Secs--50 Second Alarm Evaluation STARTED	50
50 Sat Secs--50 Second Alarm Evaluation COMPLETED	50
50 Sat Secs--50 Second Alarm Evaluation NOT COMPLETED	0
100Sat Secs-100 Second Alarm Evaluation STARTED	50
100Sat Secs-100 Second Alarm Evaluation COMPLETED	50
100Sat Secs-100 Second Alarm Evaluation NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infants With Oxygen Level Monitoring n=50 Participants In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
Age, Categorical <=18 years	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	0.73 years STANDARD_DEVIATION 0.02 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: All patients with complete data

Outcome measures

Outcome measures
Measure	Infants With Oxygen Level Monitoring n=50 Participants In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. Sat Secs Off	39.9 percentage of interventions
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. Sat Secs 10	44.4 percentage of interventions
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. Sat Secs 25	48.0 percentage of interventions
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. Sat Secs 50	50.3 percentage of interventions
Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant. Sat Secs 100	53.2 percentage of interventions

Adverse Events

Infants With Oxygen Level Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fran Haury, RRT Research Coordinator

Covidien

Phone: 303 305-2314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60