Study title:
Cordillera prototype device testing: Demonstrate that the Cordillera prototype device is able to safely and effectively maintain passenger peripheral oxygen saturation at simulated altitudes up to and including 40,000 ft (12,192 m).

Investigator:
Dr. Med. Andres Kunz, Simisola Elizabeth Oke & Onayomi Rosenior-Patten

Participants wanted for scientific study
We are seeking to recruit healthy men and non-pregnant women between the ages of 18 and 65, who are English speaking or who possess a good command of English. Participants will ideally range from athletic, with high muscle mass, to sedentry with a low muscle:fat ratio.

Aim of the study:
We want to demonstarte that a novel emergency oxygen device called the Cordillera prototype device, designed by Aviation Works Ltd. is able to continuously supply users with a flow of gas that will protect against low blood oxygen saturation at high altitude. This research will also collect information about the comfort and useability of the device. The device provides oxygen which will be mixed with a small amount of carbon dioxide.

Study schedule and duration:  
This study involves 1 screening appointment at either the Fliegerärztliches Institut (FAI) Dubendorf, Zurich, Switzerland or Medbase Lowenstrasse, and 2 appointments at the FAI. The study will be conducted in a hypobaric chamber which is a small room in which the pressure can be reduced to simulate different altitudes. While in the chamber, at various times you will be required to wear the Cordillera prototype device mask for testing. 

The 3 appointments you will be required to attend are:

  1. A screening visit at which you will have some simple medical examinations done by a qualified medical doctor. This will take up to 1 hour
  2. Test visit 1 during which you will be exposed to a maximum simulated altitude of 25,000 ft. This will take up to 7 hours
  3. Test visit 2 during which you will be exposed to a maximum simulated altitude of 40,000 ft. This will take up to 5 hours

On the test days, you will undergo a physical medical assessment and complete questionnaires to confirm your health status and identify any symptoms you may have prior to testing. You will then be shown the novel device and be given a tutorial on how it works before being fitted with the device by an investigator. During test visits 1 and 2, you will spend approximately 4 and 2 hours in a hypobaric atmosphere respectively using the novel device mask. Throughout testing in the chamber, you will be fitted with sensors that attach to the fingers and forehead to enable us to monitor your heart rate, blood oxygen level and brain oxygen level, we will also assess your blood pressure. The device is also fitted with sensors to measure the gas content of what you breathe in and out. All measures will be taken non-invasively. 

Remuneration:
If you participate in this project, you will receive a maximum of 450 CHF on full completion of the study. If for any reason you are unable to complete the whole study you will receive a pro-rated amount (based on the amount of time spent in the study). This will include 50 CHF for attendance to the screening day and each testing visit will be paid at a rate of 150-200 CHF per day (approximately 35 CHF per hour). 

The total compensation will be paid following full completion of the study.  Your participation will have no financial consequences for you or your health insurance. 

Benefits:
There is no intended clinical benefit to you as a volunteer. You will gain personal experience of simulated altitude and increased understanding of the environmental conditions experienced at high altitude. This study will provide important data to help certify a product that could improve air passenger travel.

All data collected will be treated confidentially. Participants should not expect any medical benefit.

If you are interested in taking part in the study and satisfy the above-mentioned criteria, please contact:

Onayomi Rosenior-Patten, Caeli Nova. Unit 6 The Hangar, Perseverance Works, 38 Kingsland Road, E2 8DD, London, United Kingdom via email on caelinovamedical@caelinova.com or via telephone on +44 741 5622 808

Apply as a trials participant