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NCT00179972 Clinical Trial

Evaluation of Pulse Oximetry Sensors in Neonates

Premature Birth Clinical Trial

Official title:
Evaluation of Pulse Oximetry Sensors in Neonates

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00179972
Other study ID # 2005-196N
Secondary ID
Status Terminated
Phase N/A
First received September 14, 2005
Last updated July 29, 2015
Start date September 2005
Est. completion date May 2010

Study information
Verified date July 2015
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 32
Est. completion date May 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Weeks
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago Medtronic - MITG

Country where clinical trial is conducted

United States, 

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