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

April 8, 2019 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, non smoking, normal BMI

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fresh air
2 litres of fresh air
Other: Fresh air
Fresh air insufflation of 2 L/min toward mouth/nose.
No Intervention: no fresh air
no supply of fresh air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: 25 minutes
Time to reaching a threshold of physiology parameters or time limit
25 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiology
Time Frame: 25 minutes
Values of Physiology parameters
25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Ullevaal University Hospital

Investigators

  • Study Director: Hanne Klausen, PhD, Director, Department for Anaesthesia and Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2019

Primary Completion (Anticipated)

June 8, 2019

Study Completion (Anticipated)

June 20, 2021

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/2478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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