PRecision Integrated Saturation Monitor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-12
SponsorLe Bonheur Children's Hospital
About this trial
The purpose of this study is to find out if an abdominal pulse oximeter device is as accurate as a conventional fingertip pulse oximeter in pediatric patients. In this study, we will be collecting data from your medical record while you are being treated in the hospital for your clinical care. Your baby will be in the study for 3 days. There will be no additional study visits. We will collect information already being obtained while your baby is at the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
0-12 months of age. (Must be less than 1 year of life for the pulse oximeter portion of the study) Weight greater than 2 Kg at time of study
Admitted to an intensive care unit. (Not applicable for outpatient cohort)
Arterial line in place as standard of care (Not applicable for outpatient cohort)
Informed consent provided by parent or LAR.
Disqualifiers
Open Sternum
Skin abnormalities at the proposed sensor site (e.g., rash, eczema, wounds, stoma, or infection)
Known allergy or sensitivity to adhesives or materials used in the sensor
Excessive movement or irritability that precludes safe and effective placement of the sensor
Trial population
Eligible infants hospitalized in the intensive care unit (PICU, PCVICU,NICU) who have already had an arterial line placed and on continuous pulse oximetry monitoring will be considered for enrollment and will be identified and approached for participation during their admission.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
vital sign monitoring
DeviceThe intervention will be to evaluate abdominal SpO2 against both traditional fingertip readings and gold standard SaO2 measurements by collecting routine data from the medical chart that was performed as standard of care.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Abdominal SpO2 versus SaO2
The primary outcome is the accuracy of abdominal SpO₂ versus SaO₂, measured as root mean square error (RMSE); target ≤ 3.0% RMSE.
Time frame
From enrollment to end of study at 72 hours.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Le Bonheur Children's Hospital
Lead sponsor
The Consortium for Technology & Innovation in Pediatrics (CTIP)
Collaborator
Source ClinicalTrials.gov