- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041531
Triple H ODC Trial (3H-ODC)
Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket
Study Overview
Status
Intervention / Treatment
Detailed Description
The ODC is a function of pO2 and SO2. pO2, the independent variable, is plotted on the x axis, SO2 on the y axis. For the determination of this function, a pairwise measurement of pO2 and the corresponding SO2 is to be performed. Using nonlinear regression analysis, the ODC can be fitted to the measured points that describe the relation of pO2 and SO2 and characteristic parameters like p50 value and inflection points can be calculated.
To measure the ODC under the conditions of the Triple H Syndrome (Hypoxie, Hypercapnia, Hypothermia), the temperature and the pCO2 have to be changed and controlled during the measurement. No commercially available instrument is able to obtain this. Therefore, we envisaged the development of an entirely new approach.
In the 3H ODC trial venous blood will be drawn from 18 - 40 years old female and male volunteers by a unique venipuncture. The participants have to be in a fasted situation, ASA I and nonsmokers. The blood sample will be immediately pseudonymized and stored on ice and a venous blood gas analysis will be carried out (pH, Hb, COHb, MetHb, FHb). Simultaneous to the main measurement, 2,3 BPG will be quantified by an ELISA test and any unknown hemoglobinopathy will be excluded by Hemoglobin Electrophoresis. In the 3H ODC trial 4 different pCO2 levels and 4 different temperatures will be analyzed in the resulting 16 combinations. In each round a lot of ODCs will be measured, the measurement chamber will be filled with participants blood samples in a randomized manner. After the measurements, the blood samples will be discarded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Innsbruck, Austria, 6020
- General and Surgical Critical Care Medicine, Medical University of Innsbruck
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-40 years
- fasted situation
- ASA I
- Informed Consent
Exclusion Criteria:
- any drug abuse
- any drug intake within the last 10 days
- smoking
- known hemoglobinopathy
- relevant illness within last 14 days
- relevant blood loss within last 14 days
- pregnancy or breast-feeding
- participation in any pharmacological study
- exposure to high altitude (> 3000 m) within last 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of p50 in different levels of hypercapnia and hypothermia
Time Frame: day 1
|
amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of p50 shift due to sex
Time Frame: day 1
|
amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)
|
day 1
|
amount of inflection point in different levels of hypercapnia and hypothermia
Time Frame: day 1
|
amount of inflection point in mmHg
|
day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mathias Ströhle, MD, Medical University Innsbruck
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1123/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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