|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 November 2016 |
|
Main ID: |
NCT01654913 |
|
Date of registration:
|
16/07/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Influence of Oxygen on Non-invasive Measurement of Hemoglobin
Hb-O2 |
|
Scientific title:
|
Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200) |
|
Date of first enrolment:
|
July 2012 |
|
Target sample size:
|
47 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01654913 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- adult patients scheduled for a potentially hemorrhagic surgical procedure
Exclusion Criteria:
- anomaly (malformation, infection, swelling, irritation, ulceration, degenerative
changes or significant edema) of the fingers,
- tremors.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anesthesia
|
|
Intervention(s)
|
|
Device: hemoglobin measurement
|
|
Primary Outcome(s)
|
|
influence of the inspired oxygen fraction on the noninvasive measurement of hemoglobin (Pronto 7 and NBM-200 devices)
[Time Frame: one year (end of the recrutement period)]
|
|
Secondary Outcome(s)
|
|
agreement between the noninvasive methods of measurement of hemoglobin and the laboratory analysis
[Time Frame: one year (end of the recrutement period)]
|
|
Secondary ID(s)
|
|
2012-A00416-37
|
|
2012/16
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|