Clinical trial NCT04233827: Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Official title: Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulse Oximetry
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 800
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.

Brief summary: This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Detailed description: Maxim Vital Sign study is a 2 part, investigator initiated observational study with Maxim Integrated aimed to compare vital sign readings using 2 prototype versions of new cell phone based mobile biosensors with standard of care (SOC). Adult subjects will be recruited from UCSD outpatient clinics, AVRC clinic, emergency department (ED), and hospitals. Vital signs will be measured using cell phone based mobile biosensors and SOC.

For Phase 1, up to 800 subjects will be recruited (700 adults and up to 100 adolescents). 250 subjects (200 adults and up to 50 adolescents) will participate in phase 1a and 550 subjects (500 adults and up to 50 adolescents) will participate in phase 1b. An additional group of 30 adult subjects will be recruited from outpatient clinics for participation in phase 2.

Phase 1a:

Two identical copies of the device will be tested during the first part of phase 1 with a total of 125 subjects (100 adults and up to 25 adolescents). Each prototype version will be tested on up to 125 subjects (100 adults and 25 adolescents) and compared to readings obtained by Welch-Allyn Spot Vital Signs monitor. Data will be obtained on the usability and accuracy of the measurements with each initial prototype. Measurement particularly of SpO2 depends on accurate finger position. Current SpO2 monitors encase the finger and immobilize it in order to obtain an accurate measurement. Maxim Integrated, in collaboration with DD Studios, Carlsbad CA, and Specialists in Global Health, Encinitas CA, have developed prototypes, which will be tested to inform design flaws in future prototypes.

Phase 1b:

Based on the results from phase 1a, one of the prototypes will be selected for further testing (the one with the least within-instrument variation). During Phase 1b, vital sign readings will be collected with the selected Maxim biosensor prototype and one of the Welch-Allyn Spot Vital Signs monitor simultaneously. The subjects will be recruited from both outpatient and hospital settings for accuracy and usability. A total of 550 subjects (500 adults and 50 adolescents) will be recruited for this part of phase 1.

Eligibility criteria: Inclusion Criteria:

1. Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.
2. Subjects must be willing to use the mobile device and answer questions regarding their experience.

Exclusion Criteria:

Individuals with prior or recent injury to one or both of their index fingers that would prevent or interfere with the use of Maxim biosensor.

Primary outcomes:
measure: Accuracy of vital signs (HR and SpO2)
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD AntiViral Research Center
state: California
Study officials:
affiliation: UC San Diego
name: Sara H Browne, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Browne SH, Bernstein M, Pan SC, Gonzalez Garcia J, Easson CA, Huang CC, Vaida F. Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients. Chest. 2021 Feb;159(2):724-732. doi: 10.1016/j.chest.2020.08.2104. Epub 2020 Sep 11.