Hypoxia3H-ODCNCT04041531
Triple H ODC Trial
A study testing blood sampling in people with Hypoxia and Hypothermia, Accidental, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypothermia, Accidental, Hypercapnia
- What is being tested?
- blood sampling
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 26 Aug 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years
- fasted situation
- ASA I
- Informed Consent
Who cannot join
- 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
Show all 9Show fewer
- pregnancy or breast-feeding
- participation in any pharmacological study
- exposure to high altitude (> 3000 m) within last 4 weeks
Trial locations and contacts
1 site in 1 country.
Austria1 site
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, 6020
About this study
Official title: Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket
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.
Read the 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.
- Being tested
- blood sampling
- Medical subject headings
- Hypoxia, Hypothermia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
venous blood sampling for oxygen affinity in-vitro test
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of p50 in different levels of hypercapnia and hypothermia
amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)
Measured: day 1
Secondary outcomes (2)
amount of p50 shift due to sex
amount of p50 in mmHg (p50 = pO2 when oxygen saturation of hemoglobin is 50%)
Measured: day 1
amount of inflection point in different levels of hypercapnia and hypothermia
amount of inflection point in mmHg
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start26 Aug 2019
- Primary completion30 Nov 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Factorial
- Model description
- 16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Mathias Ströhle, MD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041531
- Sponsor's protocol ID
- 1123/2019
- Acronym
- 3H-ODC
- Status last verified
- Sep 2020
- First submitted
- 26 Jul 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Oxygen Dissociation Curve Under the Conditions of an Avalanche Burial With an Air Pocket
- ClinicalTrials.gov ID
- NCT04041531
- Acronym / sponsor ID
- 3H-ODC / 1123/2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Model description
- 16 combinations of 4 levels of pCO2 and 4 levels of temperature will be assessed for each participant
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-40 years
- fasted situation
- ASA I
- Informed Consent
Key exclusion criteria (9 listed)
- any drug abuse
- any drug intake within the last 10 days
- smoking
- known hemoglobinopathy
- relevant illness within last 14 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingvenous blood sampling for oxygen affinity in-vitro test | Other | – |
Primary outcome
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%)
2 secondary outcomes
amount of p50 shift due to sex
Time frame: day 1
amount of inflection point in different levels of hypercapnia and hypothermia
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Ströhle, MD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Hypoxia and Hypothermia, Accidental, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of p50 in different levels of hypercapnia and hypothermia (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.