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Evaluation of Pulse Oximetry Sensors in Neonates
This study is currently recruiting participants.
Study NCT00179972   Information provided by Children's Memorial Hospital
First Received: September 14, 2005   Last Updated: January 23, 2006   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 14, 2005
January 23, 2006
September 2005
 
 
Complete list of historical versions of study NCT00179972 on ClinicalTrials.gov Archive Site
 
 
 
Evaluation of Pulse Oximetry Sensors in Neonates
Evaluation of Pulse Oximetry Sensors in Neonates

The purpose of this study is to evaluate sensor longevity and skin integrity with two different models of neonatal pulse oximetry sensors currently used for monitoring oxygen levels in small infants.

A common method for assessing the respiratory status of hospitalized children is the use of pulse oximetry. This noninvasive device typically is placed on a finger, foot/palm of a child. Red and infrared light is shined through the tissue under the sensor and the information is sent back to a monitor for calculation of oxygen saturation. Use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood samples required for patient care. While the advantages of noninvasive pulse oximetry are significant, there are a number of factors which can negatively impact the performance of the device. Patient movement and sensor adherence to the skin have been some of the challenges to optimal device performance. While much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data is available on sensor longevity under conditions typical of clinical use. A particular challenge with neonatal pulse oximetry monitoring is insuring proper sensor adherence within the warm, moist environment of incubators used in neonatal care. Furthermore, limited data are available on the impact of sensor adherence on skin integrity in premature infants who are at high risk for skin breakdown. Objectives. The purpose of this study is to evaluate sensor longevity and impact on skin integrity in neonatal patients with two different models of pulse oximetry sensors. Research Method. A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.

 
Observational
Natural History, Cross-Sectional, Defined Population, Prospective Study
Premature Birth
Device: Adhesive and non-adhesive oximetry sensors
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
32
May 2006
 

Inclusion Criteria:

  • Gestational age < 34 weeks
  • Weight < 3.0 kg
  • Postnatal age < 2 weeks
  • Anticipated pulse oximetry monitoring for at least 14 days

Exclusion Criteria:

  • Presence of any skin irritation or breakdown on either foot
  • Foot impediments which would preclude proper placement of the test sensors
  • Known allergies to adhesive materials
Both
up to 2 Weeks
No
Contact: Barbara A Fleming, RNC, MS 773-868-8955 bfleming@childrensmemorial.org
United States
 
 
NCT00179972
 
 
Children's Memorial Hospital
Nellcor Puritan Bennet
Principal Investigator: Barbara A Fleming, RNC, MS Children's Memorial Hospital
Children's Memorial Hospital
September 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.