Trial Outcomes & Findings for Quantifying the Venous Congestion Curve of a Tissue Oximetry Device (NCT NCT05592145)
NCT ID: NCT05592145
Last Updated: 2024-03-21
Results Overview
transcutaneous oximetry (StO2) of vascular occlusion test at 0.5 hours - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Hour 0.5
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
ViOptix T.Ox
ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.
ViOptix: ViOptix machine
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ViOptix T.Ox
n=38 Participants
ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.
ViOptix: ViOptix machine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
|
Age, Continuous
|
25.5 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: Hour 0.5transcutaneous oximetry (StO2) of vascular occlusion test at 0.5 hours - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement
Outcome measures
| Measure |
ViOptix T.Ox
n=38 Participants
ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.
ViOptix: ViOptix machine
|
|---|---|
|
Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours
|
70.353 percentage of oxygen saturation
Interval 0.0 to 100.0
|
Adverse Events
ViOptix T.Ox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Renea Jennings RN,BSN,CCRP
Atrium Health Wake Forest Baptist
Phone: 336-716-4417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place