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Triple H ODC Trial (3H-ODC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04041531
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 5, 2019
Institute of Mountain Emergency Medicine
Information provided by (Responsible Party):
Medical University Innsbruck

Brief Summary:
In an avalanche burial with an air pocket hypercapnia (and hypoxia) develops within few minutes, hypercapnia increases the rate of cooling and therefore the development of hypothermia. The Triple H Syndrome (Hypoxia, Hypercapnia, Hypothermia) occurs. This specific combination of the three parameters is unique for avalanche burial with an air pocket. Every single parameter has a substantial effect on the hemoglobin-oxygen dissociation curve, but until now no study described the combination of these three parameters. This curve will be measured under these specific conditions in a specifically developed in vitro model, to quantify its shifts and to show if there are combined effects of pCO2 and temperature. The newly developed method will be validated in comparison with an established method. The project will be performed with whole blood, drawn by healthy volunteers, in an experimental setting. The samples will be blinded to the investigator and analyzed in a randomized manner.

Condition or disease Intervention/treatment Phase
Hypoxia Hypothermia, Accidental Hypercapnia Avalanche, Landslide, or Mudslide Other: blood sampling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Factorial Assignment
Intervention Model Description: 16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket
Estimated Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: blood sampling
    venous blood sampling for oxygen affinity in-vitro test

Primary Outcome Measures :
  1. 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%)

Secondary Outcome Measures :
  1. 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%)

  2. amount of inflection point in different levels of hypercapnia and hypothermia [ Time Frame: day 1 ]
    amount of inflection point in mmHg

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04041531

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Contact: Simon Woyke, MD 004369918396158
Contact: Giacomo Strapazzon, MD, PhD 00390471055543

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General and Surgical Critical Care Medicine, Medical University of Innsbruck Not yet recruiting
Innsbruck, Austria, 6020
Contact: Mathias Ströhle, MD    00435125080496   
Principal Investigator: Mathias Ströhle, MD         
Principal Investigator: Simon Woyke, MD         
Sponsors and Collaborators
Medical University Innsbruck
Institute of Mountain Emergency Medicine
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Principal Investigator: Mathias Ströhle, MD Medical University Innsbruck

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Responsible Party: Medical University Innsbruck Identifier: NCT04041531     History of Changes
Other Study ID Numbers: 1123/2019
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Signs and Symptoms, Respiratory
Signs and Symptoms
Body Temperature Changes