Physiological Values When Breathing in an Air-pocket. Mountain Lab 2019 (ML2019)

Accident Caused by Snow Avalanche Clinical Trial

Official title:

Gas Diffusion in and Out of an Air Pocket After a Simulated Snow Avalanche and Its Impacts on Human Physiological Parameters.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03911011
• Other study ID #: 2018/2478
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: June 20, 2021

Study information

• Verified date: February 2019
• Source: Haukeland University Hospital
• Contact: Oyvind Thomassen, PhD
• Phone: +4797718721
• Email: oyvt[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The literature describes and report neurologic intact patients surviving an avalanche several hours after they were buried. The most important factor for surviving more than 15-35 min of burial is considered to be the presence of an air-filled space around the head and neck, termed an air pocket. Little is known how the inspired air is influenced by the patients breathing and how oxygen and carbon dioxide diffuse through snow.

Description:

In a controlled and simulated avalanche scenario the investigators want to investigate how oxygen (O2) and carbon dioxide (CO2) diffuse and how rebreathing of CO2 in addition to mild hypoxia influence standardized physiological parameters in two scenarios: Fresh air and no fresh air delivered into the air pocket. The project is a field study designed to measure and document gas diffusion through snow. The outcome measures are: (1) Concentration of O2 and CO2 in the air pocket and 50 cm from the pocket. (2) Time interval for development of threshold values for concentration of O2 and CO2. The investigators will also monitor physiologic measures such as: Electrocardiogram (ECG), continuous invasive blood pressure, cerebral oximetry, continuous pulse oximetry, transthoracic impedance, and gas content in expired air. Subjective evaluation of comfort will also be scored. Twenty healthy young volunteers with written consent to participate will be used as test subjects.

The study may have a clinical consequence for better outcome, for victims of avalanches by providing additional air or oxygen close to the patient. We will also measure specific body measures and spirometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 20, 2021
• Est. primary completion date: June 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy, non smoking, normal BMI

Exclusion Criteria:

Related Conditions & MeSH terms

• Accident Caused by Snow Avalanche

Intervention

Other:
• Fresh air
Fresh air insufflation of 2 L/min toward mouth/nose.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiology	Values of Physiology parameters	25 minutes
Primary	Time	Time to reaching a threshold of physiology parameters or time limit	25 minutes