Controlled Desaturation Study for TipTraQ SpO2 Performance Validation

NCT06634693 | Completed

• 2 other identifiers: TipTraQ SpO2 validation study21-35637
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019.

Conditions

Hypoxia

Keywords

SpO2

Outcome Measures

Primary Outcomes (2)

• SaO2

  oxygen saturation of arterial blood sample measured by blood gas analysis

  During the controlled desaturation study, within 1 day

• SpO2

  Peripheral blood oxygen saturation measured through plethysmography(PPG)

  During the controlled desaturation study, within 1 day

Study Arms (1)

Heathy adult

healthy adult without pulmonary or cardiovascular disease

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults without respiratory or heart diseases

You may qualify if:

• Participant must have the ability to understand and provide written informed consent
• A participant is an adult 18-50 years of age
• Participant must be willing and able to comply with study procedures and duration
• Participant is a non-smoker or who has not smoked within 2 days before the study.

You may not qualify if:

• Participant is considered as being morbidly obese (defined as BMI \>39.5)
• Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears, forehead/skull, or other sensor sites would limit the ability to test sites needed for the study. Tattoos in the optical path would limit the ability to test sites needed for the study.
• Participants with known respiratory conditions
• Uncontrolled/severe asthma
• pneumonia/bronchitis
• shortness of breath / respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease
• Recent COVID (last 2 months)
• Participants with self-reported heart or cardiovascular conditions
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
• previous heart attack
• blocked artery
• congestive heart failure (CHF)

Sponsors & Collaborators

• PranaQ Pte. Ltd.: lead

Study Sites (1)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Bickler, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 10, 2024
• Study Start: October 10, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)