- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179972
Evaluation of Pulse Oximetry Sensors in Neonates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barbara A Fleming, RNC, MS, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-196N
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Birth
-
Shaare Zedek Medical CenterTerminatedPremature Birth of NewbornIsrael
-
University of VirginiaCompletedPremature Birth of NewbornUnited States
-
Case Western Reserve UniversityCompleted
-
University of California, San FranciscoUniversity of California, San Diego; University of California, Los Angeles; Kaiser...CompletedPremature Birth of NewbornUnited States
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenUnknownPremature Birth of NewbornBelgium
-
Universidad Complutense de MadridCompletedPremature Birth of Newborn
-
Indiana UniversityCompletedPremature LaborUnited States
-
Washington University School of MedicineUniversity of Southern CaliforniaCompletedPremature Birth of NewbornUnited States
-
Vestre Viken Hospital TrustHaukeland University HospitalActive, not recruiting
-
University of ArkansasCompletedPremature Birth of NewbornUnited States
Clinical Trials on Adhesive and non-adhesive oximetry sensors
-
Stryker Sustainability SolutionsCompletedHealthy | HypoxiaUnited States
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedWound HealingUnited States
-
Masimo CorporationCompletedHealthyUnited States
-
Birken AGCompletedWoundsSpain, France, Greece, Latvia
-
Birken AGCompletedWoundsGermany, Austria, Bulgaria, Czechia, Finland, Poland
-
Advanced Medical Solutions Ltd.Imarc Research, Inc.Recruiting
-
Embo-Flüssigkeiten A.G.Active, not recruitingCerebral Arteriovenous MalformationFrance, Denmark, Germany, Belgium, Italy
-
Dr. Markus Alfred MöhlenbruchUniversity Hospital Schleswig-HolsteinCompletedDural Arteriovenous FistulaGermany
-
Children's Mercy Hospital Kansas CityCompletedThe Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circglue)Adhesions | PhimosisUnited States
-
Duke UniversityCompletedRegional Anesthesia MorbidityUnited States