Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179972
Status:
TERMINATED
Last Update Posted:
2015-07-31
First Post:
2005-09-14
Brief Title:
Evaluation of Pulse Oximetry Sensors in Neonates
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Evaluation of Pulse Oximetry Sensors in Neonates
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of resources and loss of personnel precluded study progress No adverse events or unanticipated problems involving risks to subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 footpalm 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None