Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05581394
Other study ID # BICK-ACC-20220714
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 14, 2022
Est. completion date July 15, 2022

Study information

Verified date October 2022
Source Owlet Baby Care, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained and during different motion scenarios. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - The subject is male or female, aged =18 and <50 - The subject is in good general health with no evidence of any medical problems - The subject is fluent in both written and spoken English - The subject has provided informed consent and is willing to comply with the study procedures Exclusion Criteria: - The subject is obese (BMI>30). - The subject has a known history of heart disease, lung disease, kidney or liver disease. - Diagnosis of asthma, sleep apnea, or use of CPAP. - Subject has diabetes. - Subject has a clotting disorder. - The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. - The subject has any other serious systemic illness. - The subject is a current smoker. - Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. - The subject has a history of fainting or vasovagal response. - The subject has a history of sensitivity to local anesthesia. - The subject has a diagnosis of Raynaud's disease. - The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). - The subject is pregnant, lactating or trying to get pregnant. - The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. - The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BabySat V3
Evaluation of Accuracy of BabySat V3

Locations

Country Name City State
United States University California San Fransisco, Department of Anesthesia San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Owlet Baby Care, Inc. University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of accuracy during motion Determine the accuracy during varying degrees of motion and oxygen saturation During the oxygen desaturation assessment
See also
  Status Clinical Trial Phase
Recruiting NCT04498598 - Structural Modification In Supraglottic Airway Device N/A
Completed NCT05532670 - N600X Low Saturation Accuracy Validation
Enrolling by invitation NCT04106401 - Intravascular Volumes in Hypoxia During Antarctic Confinement N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Not yet recruiting NCT05817448 - Hypoxia-induced Autophagy in the Pathogenesis of MAP
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02801162 - Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT02943863 - Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia N/A
Completed NCT01922401 - Inverse Ratio Ventilation on Bariatric Operation N/A
Completed NCT02105298 - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study) N/A
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Completed NCT01463527 - Using Capnography to Reduce Hypoxia During Pediatric Sedation N/A
Completed NCT01507623 - Value of Capnography During Nurse Administered Propofol Sedation (NAPS) N/A
Withdrawn NCT00638040 - The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression N/A
Active, not recruiting NCT06097754 - Intermittent Exogenous Ketosis (IEK) at High Altitude N/A
Completed NCT04589923 - The VISION-Acute Study
Completed NCT05044585 - Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers N/A
Completed NCT03659513 - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Completed NCT03221387 - Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients N/A