NCT03911011

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2021

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 22, 2019

Last Update Submit

February 25, 2025

Conditions

Accident Caused by Snow Avalanche

Keywords

avalanche, survival, physiology

Outcome Measures

Primary Outcomes (1)

  • Time

    Time to reaching a threshold of physiology parameters or time limit

    25 minutes

Other Outcomes (1)

  • Physiology

    25 minutes

Study Arms (2)

Fresh air

ACTIVE COMPARATOR

2 litres of fresh air

Other: Fresh air

no fresh air

NO INTERVENTION

no supply of fresh air

Interventions

Fresh airOTHER

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

Fresh air

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be Healthy
  • Subject must be non smoking
  • Subject must have normal BMI

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

Location

Study Officials

  • Hanne Klausen, PhD

    Director, Department for Anaesthesia and Intensive Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: A field study designed as a crossover clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

April 10, 2019

Study Start

March 7, 2019

Primary Completion

June 8, 2019

Study Completion

June 20, 2021

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)