Triple H ODC Trial

NCT04041531 | Completed

• 1 other identifier: 1123/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia; Hypothermia, Accidental; Hypercapnia; Avalanche, Landslide, or Mudslide

Outcome Measures

Primary Outcomes (1)

• amount of p50 in different levels of hypercapnia and hypothermia

  amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)

  day 1

Secondary Outcomes (2)

• amount of p50 shift due to sex

  day 1

• amount of inflection point in different levels of hypercapnia and hypothermia

  day 1

Interventions

blood sampling OTHER

venous blood sampling for oxygen affinity in-vitro test

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• fasted situation
• ASA I
• Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Institute of Mountain Emergency Medicine: collaborator

Study Sites (1)

General and Surgical Critical Care Medicine, Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Hypoxia; Hypothermia; Hypercapnia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mathias Ströhle, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 1, 2019
• Study Start: August 26, 2019
• Primary Completion: November 30, 2019
• Study Completion: February 10, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)