NCT06895759

Brief Summary

Asphyxia is by far the most common cause of death after critical avalanche burial. The presence of an air pocket increases the survival chances, but expired air rich in carbon dioxide (CO2) progressively displaces oxygen (O2) in the air pocket, a phenomenon known as displacement asphyxia. In addition, an increase in the inspired concentration of CO2 (FiCO2) reduces the alveolar partial pressure of O2 (PAO2), as explained by the alveolar gas equation. Underlining this, a recent experimental porcine study showed that an increased FiCO2 is the leading cause of the decrease in PaO2. By removing CO2 in an experimental avalanche burial, normoxia persisted even after 90 minutes of burial, while, in the absence of CO2 removal, hypoxemia and hypercapnia occurred after only 10 minutes. Additionally, hypercapnia increases pulmonary vascular resistance, reduces cardiac output and can lead to life-threatening hemodynamic instability. Hypercapnia can speed up the cooling rate, and the combination of hypothermia with hypoxia and hypercapnia may result in a worse neurological outcome in completely buried avalanche patients compared to patients suffering solely hypothermic cardiac arrest. Taken together, these findings suggest that removing CO2 from the air-pocket could prevent, or at least delay, the hypercapnic condition with its deleterious consequences and consequently increase the survival after complete avalanche burial. The main aim of the study is to investigate the effectiveness of soda lime in removing CO2 while breathing into a snow air pocket, and to assess its impact on gas exchange, ventilation patterns, and hemodynamics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

10 days

First QC Date

March 14, 2025

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to reach an end-tidal CO2 or partial pressures of carbon dioxide in arterial blood (PaCO2)

    Time to reach an end-tidal CO2 (etCO2) of 70 mmHg or partial pressures of carbon dioxide in arterial blood (PaCO2) of 65 mmHg

    35 minutes

  • Time to reach an oxygen saturation (SpO2)

    Time to reach an oxygen saturation (SpO2) ≤75%

    35 minutes

Secondary Outcomes (9)

  • Difference in end-tidal CO2 (etCO2) and partial pressures of carbon dioxide in arterial blood (PaCO2)

    35 minutes

  • Partial pressure of oxygen

    35 minutes

  • Differences in inspiratory fraction of CO2 (FiCO2) and O2 (FiO2)

    35 minutes

  • Difference in minute ventilation (VE)

    35 minutes

  • Difference in cardiac output (CO)

    35 minutes

  • +4 more secondary outcomes

Study Arms (2)

Breathing with soda lime

EXPERIMENTAL

Respiration into a snow air pocket through an experimental rebreathing circuit with the integration of a soda lime canister.

Device: Soda lime

Breathing without soda lime

SHAM COMPARATOR

Respiration into a snow air pocket through an experimental rebreathing circuit without the integration of a soda lime canister.

Device: Sham

Interventions

Soda limeDEVICE

Respiration into a snow air pocket through an experimental rebreathing circuit with the integration of a soda lime canister.

Breathing with soda lime
ShamDEVICE

Respiration into a snow air pocket through an experimental rebreathing circuit without the integration of a soda lime canister.

Breathing without soda lime

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 - 60 yrs.
  • Body mass index \< 30 kg/m2
  • ASA class ≤2
  • Providing informed and written consent

You may not qualify if:

  • ASA \>2
  • Pregnancy
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

terraXCube

Bolzano, Italy/BZ, 39100, Italy

Location

Study Officials

  • Simon Rauch, MD, PhD

    Eurac research, Institute of Mountain Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 26, 2025

Study Start

March 20, 2025

Primary Completion

March 30, 2025

Study Completion

December 31, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations