Triple H ODC Trial
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2019 |
| First Submitted: | 07/25/2019 |
| Estimated Enrollment Submitted: | 07/30/2019 |
| First Posted: | 07/31/2019 |
| Last Update Submitted: | 06/01/2020 |
| Last Update Posted: | 06/03/2020 |
| Actual Study Start Date: | 08/25/2019 |
| Estimated Primary Completion Date: | 11/29/2019 |
| Estimated Study Completion Date: | 08/30/2021 |
Condition or disease
Intervention/treatment
Other: blood sampling
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. amount of p50 in different levels of hypercapnia and hypothermia [day 1]
Secondary Outcome Measures
1. amount of p50 shift due to sex [day 1]
2. amount of inflection point in different levels of hypercapnia and hypothermia [day 1]
