Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05693168
NCT05693168CompletedNot Applicable

Accuracy of Pulse Oximeter With Profound Hypoxia

Sibel Health Inc.2 sites in 1 country12 target enrollmentStarted: June 23, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The subject is male or female, between the ages of 18 and 55 years.
  • •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

  • •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 has 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
  • •Th 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

Outcomes

Primary Outcomes

ARMS of SpO2 Measurements with ANNE Limb compared to SaO2

Time Frame: 1 hour

Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Pulse Oximeter and Respiratory Rate TestHypoxiaHypocapniaHypercapnia
NCT03797300Spry Health12
Completed
Not Applicable
Pulse Oximeter TestHypoxia
NCT03569163Spry Health11
Completed
Not Applicable
EmbracePlus SpO2 Accuracy ValidationOximetry
NCT04964609Empatica, Inc.14
Completed
Not Applicable
Accuracy of Pulse Oximeters With Profound HypoxiaOximetry
NCT04324385Compumedics Limited12
Completed
Not Applicable
Controlled Desaturation Study for TipTraQ SpO2 Performance ValidationHypoxia
NCT06634693PranaQ Pte. Ltd.12