Evaluation of Pulse Oximetry Sensors in Neonates

This study has been terminated.
Sponsor:
Collaborator:
Covidien
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179972
First received: September 14, 2005
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Premature Birth
Device: Adhesive and non-adhesive oximetry sensors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pulse Oximetry Sensors in Neonates

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Estimated Enrollment: 32
Study Start Date: September 2005
Estimated Study Completion Date: May 2006
Intervention Details:
    Device: Adhesive and non-adhesive oximetry sensors
    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.
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.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

NICU of Children's Memorial Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179972

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Covidien
Investigators
Principal Investigator: Barbara A Fleming, RNC, MS Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Barbara Fleming, RN, MSN / Clinical Nurse Specialist-NICU, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179972     History of Changes
Other Study ID Numbers: 2005-196N
Study First Received: September 14, 2005
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Pulse oximetry
Pulse oximetry sensors
Skin Integrity
Prematurity
Neonatal Intensive Care Unit
Infant, premature

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014