NCT01085539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 5, 2012

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

March 10, 2010

Results QC Date

May 2, 2012

Last Update Submit

August 5, 2014

Conditions

Hypoxemia

Keywords

neonatal intensive careinfant pulse oximetry

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 hours

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

neonates in the intensive care unit

You may qualify if:

  • Infants in the NICU continuously monitored by pulse oximetry

You may not qualify if:

  • Infants whose legal guardians do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The study oximeter's detection could have been 60 seconds before or after the recorded clinical intervention because of sampling bias. There were many desaturations that led to alarms that had no interventions.

Results Point of Contact

Title
Fran Haury, RRT Research Coordinator
Organization
Covidien
fran.haury@covidien.com
303 305-2314

Study Officials

  • Roger Mecca, MD

    Medtronic - MITG

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 12, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

August 7, 2014

Results First Posted

September 5, 2012

Record last verified: 2014-08

Locations

US(3)