Oxygen Saturation Alarms in the Neonatal Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01085539
First received: March 10, 2010
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: May 2, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hypoxemia

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 5 periods

Period 1:   Sat Secs Off--No Alarm Evaluation
    Infants With Oxygen Level Monitoring  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  

Period 2:   10 Sat Secs--10 Second Alarm Evaluation
    Infants With Oxygen Level Monitoring  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  

Period 3:   25 Sat Secs--25 Second Alarm Evaluation
    Infants With Oxygen Level Monitoring  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  

Period 4:   50 Sat Secs--50 Second Alarm Evaluation
    Infants With Oxygen Level Monitoring  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  

Period 5:   100Sat Secs-100 Second Alarm Evaluation
    Infants With Oxygen Level Monitoring  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Infants With Oxygen Level Monitoring  
Number of Participants  
[units: participants]
  50  
Age  
[units: participants]
 
<=18 years     50  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  0.73  ± 0.02  
Gender  
[units: participants]
 
Female     21  
Male     29  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures

1.  Primary:   Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant.   [ Time Frame: 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Fran Haury, RRT Research Coordinator
Organization: Covidien
phone: 303 305-2314
e-mail: fran.haury@covidien.com


No publications provided


Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01085539     History of Changes
Other Study ID Numbers: COV-M0-PO-A108
Study First Received: March 10, 2010
Results First Received: May 2, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board