Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03082105
Other study ID # V/16/13
Secondary ID
Status Completed
Phase N/A
First received March 8, 2017
Last updated March 10, 2017
Start date December 1, 2013
Est. completion date March 9, 2014

Study information

Verified date March 2017
Source Institute of Mountain Emergency Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L. Every subject performed three tests on different days with varying snow characteristics. Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 9, 2014
Est. primary completion date March 9, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy volunteers with an age above 18yr-old, physically active.

- Volunteers have been informed and have signed consent.

Exclusion Criteria:

- Lack of consent.

- Chronic previous illness of the respiratory tract or of the cardiovascular system.

- Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).

- Eurac employees.

Study Design


Intervention

Other:
Breathing in snow
Breathing in snow with different physical properties

Locations

Country Name City State
Italy Institute of Mountain Emergency Medicine, Eurac Research Bolzano Bz

Sponsors (2)

Lead Sponsor Collaborator
Institute of Mountain Emergency Medicine Medical University Innsbruck

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. — View Citation

Haegeli P, Falk M, Brugger H, Etter HJ, Boyd J. Comparison of avalanche survival patterns in Canada and Switzerland. CMAJ. 2011 Apr 19;183(7):789-95. doi: 10.1503/cmaj.101435. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary SpO2 (%) Continuous monitoring Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Secondary EtCO2 (mmHg) Continuous monitoring Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Secondary Cause of interruption SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache) Timepoint immediately before interruption of snow-breathing phase (max 30min)
Secondary VE (L/min) Continuous monitoring Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
Secondary rSO2 (%) Continuous monitoring Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
See also
  Status Clinical Trial Phase
Completed NCT02845076 - Weaning From Noninvasive Ventilation N/A
Recruiting NCT05008211 - Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients N/A
Recruiting NCT03238339 - The Clinical Application and Popularization of Portable Home Noninvasive Ventilator
Recruiting NCT06047405 - NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP N/A
Completed NCT04108819 - Ketogenic Diet for Obesity Hypoventilation Syndrome N/A
Recruiting NCT02874339 - High Flow Nasal Oxygen Versus VNI in Acute Hypercapnic Cardiogenic Pulmonary Edema N/A
Not yet recruiting NCT05497986 - Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure N/A
Completed NCT01987661 - The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD N/A
Completed NCT03398239 - Comparison of BPAP ST/T and BPAP ST / T Mode With AVAPS for Hypercapnic Respiratory Failure in ED N/A
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A
Completed NCT04072848 - Mathematically Arterialised Testing of Hypercapnic Subjects Study
Not yet recruiting NCT04131660 - Efficacy of Volume Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation N/A
Completed NCT02699112 - Cardiac and Respiratory Function With Non-invasive Ventilation
Completed NCT01523470 - Withdrawal of Non-invasive Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Acute Hypercapnic Respiratory Failure Phase 3
Active, not recruiting NCT04709562 - Clinical Stabilization of Hypercapnia: NIPPV v HVNI N/A
Not yet recruiting NCT06064409 - Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
Recruiting NCT04351906 - Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome N/A
Not yet recruiting NCT06367686 - Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor
Completed NCT03406572 - Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure N/A
Active, not recruiting NCT03364946 - High Flow Therapy in ICUs Across Ibero America