Study Stopped
Limited staff availability
Alternate Methodology of Pulse Oximeter Validation
1 other identifier
interventional
2
1 country
1
Brief Summary
This study will determine if the replacement of the measured arterial blood oxygen saturation with expired (end-tidal) oxygen value is an acceptable method to calculate the accuracy of pulse oximeters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2019
CompletedResults Posted
Study results publicly available
August 11, 2026
CompletedAugust 11, 2026
March 1, 2023
3 months
August 9, 2018
April 9, 2026
July 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Accuracy of FDA-approved Pulse Oximeter When Calculated With RespirAct-derived End-tidal PAO2 Values
The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
1 study day
Accuracy of FDA-approved Pulse Oximeter When Calculated With Co-oximeter Measured Arterial PaO2 Values
The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
1 study day
PAO2 Values
A\[RMS\] of RespirAct-derived end-tidal PAO2 values with co-oximeter measured arterial PaO2 values. The unit of measure of accuracy is called Accuracy Root Mean Square Error (A\[RMS\]) and is a composite value of bias and precision. A\[RMS\] is reported as a single percentage value representing the overall accuracy of a medical device with lower values indicating better performance.
1 study day
Secondary Outcomes (2)
Accuracy, A[RMS], When a Step-wise Desaturation Sequence is Used Against a Slope Desaturation Sequence.
1 study day
Level of PaCO2 (Hypocapnia Versus Normocapnia)
1 study day
Study Arms (5)
RespirAct Step-Wise Normocapnia desaturation sequence
EXPERIMENTALReduction in oxygen saturation 100 to 70% in approximate 5% steps.
RespirAct Slope Normocapnia desaturation sequence
EXPERIMENTALReduction in oxygen saturation 100 to 70% as gradual slope.
RespirAct Step-Wise Hypocapnia desaturation sequence
EXPERIMENTALReduction in oxygen saturation 100 to 70% in approximate 5% steps.
RespirAct Slope Hypocapnia desaturation sequence
EXPERIMENTALReduction in oxygen saturation 100 to 70% as gradual slope.
ROBD Step-Wise desaturation sequence
ACTIVE COMPARATORROBD = Reduced Oxygen Breathing Device. Reduction in oxygen saturation 100 to 70% in approximate 5% steps. This represents the standard type of desaturation sequence for pulse oximeter accuracy testing.
Interventions
Blood carbon dioxide controlled at normal value (normocapnia).
Blood carbon dioxide controlled at normal value (normocapnia).
Blood carbon dioxide controlled at lower than normal value (hypocapnia).
Blood carbon dioxide controlled at lower than normal value (hypocapnia).
Blood carbon dioxide is controlled at normal or lower value by subject's own breathing rate.
Eligibility Criteria
You may qualify if:
- Aged 18 - 50 years
- Subject is willing to provide written informed consent and is able to comply with anticipated study procedures
You may not qualify if:
- Body Mass Index (BMI) \< 18.0 or \> 30.0
- Known significant respiratory, cardiovascular or medical condition that precludes study participation as judged by investigator
- Anemia \[hemoglobin value below lower range of normal for gender\]
- Abnormal hemoglobin electrophoresis result
- Exposure to nicotine \[positive test at screening or study day\]
- Abnormal drug screen \[positive test at screening or on day of study\]
- Positive pregnancy test for females \[serum test at screening; urine test on study day\]
- Abnormal Allen's test for collateral circulation
- Abnormal Electrocardiogram
- Abnormal Pulmonary Function Test
- Abnormal venous blood gas result
- Intolerance of facemask
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University
Durham, North Carolina, 27710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David MacLeod, MBBS
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
David B MacLeod, FRCA
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
September 26, 2018
Primary Completion
January 2, 2019
Study Completion
January 3, 2019
Last Updated
August 11, 2026
Results First Posted
August 11, 2026
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share