3H-ODC: Triple H ODC Trial

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT04041531
• Collaborator: Institute of Mountain Emergency Medicine (Other)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Factorial Assignment
• Intervention Model Description: 16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant16 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
• Actual Study Start Date: Aug 26, 2019
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Feb 10, 2020

Outcome Measures

Primary Outcome Measures

1. amount of p50 in different levels of hypercapnia and hypothermia [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 [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 [day 1]

   amount of inflection point in mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General and Surgical Critical Care Medicine, Medical University of Innsbruck	Innsbruck		Austria	6020

Sponsors and Collaborators

• Medical University Innsbruck
• Institute of Mountain Emergency Medicine

Investigators

• Principal Investigator: Mathias Ströhle, MD, Medical University Innsbruck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT04041531
• Other Study ID Numbers: 1123/2019
• First Posted: Aug 1, 2019
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoxia; Hypothermia; Hypercapnia

Study Results

No Results Posted as of Sep 9, 2020