Difference in time until onset of symptoms and recovery between hypobaric and normobaric hypoxia

Recruiting

Conditions: hypoxie symptomen en resipiratoire veranderingen bij hypoxieblootstelling bij gezonde deelnemers
oxygen deficiency
Reduction in blood oxygen saturation

Registration Number: NL-OMON56865

Lead Sponsor: Koninklijke luchtmacht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

Aircrew between 18 and 62 years old
Previous hypoxia training
In possession of an active aeromedical certificate (fit to fly)
Willing and able to provide informed consent

Exclusion Criteria

Significant adverse event after a previous hypoxia training
Ear drum perforation in medical history
Claustrophobia
Pregnancy
Exposure to altitude for longer than one week higher than 8000ft 3 months prior
to research
Smokers
Does not comprehend study requirements and/or is unable to comply with study
procedures or pre-session restrictions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in time until onset of the first hypoxia symptom and the severity of<br /><br>hypoxia symptoms between Hypobaric Hypoxia (HH) in the hypobaric chamber and<br /><br>Normobaric Hypoxia (NH) in the ROBD at a simulated altitude of 18000 ft. The<br /><br>endpoint is an composite endpoint. At an altitude of 18,000 ft, we expect all<br /><br>test subjects to experience hypoxia symptoms. In the unlikely event that they<br /><br>do not feel their own symptoms. The crossing of their TUC will be considered<br /><br>their first sign of hypoxia. In the unlikely event that test subjects will not<br /><br>experience symptoms and the TUC will not be crossed, censoring will be applied. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters:<br /><br>I. Difference in time to initiation of recovery (after recognition of the third<br /><br>symptom) between HH and NH.<br /><br>II. Difference in severity of symptoms in HH and NH.<br /><br>III. Difference in respiratory and oxygenation parameters during the different<br /><br>exposures to hypoxia, by measuring the following parameters:<br /><br>a. Oxygen saturation (SpO2)<br /><br>b. Rate of decline of SpO2<br /><br>c. Respiratory Rate (RR)<br /><br>d. Tidal volume (TV)<br /><br>e. Minute ventilation (Ve)<br /><br>f. Partial pressure of end tidal CO2 (PETCO2)<br /><br>g. Partial pressure of end tidal O2 (PETO2)</p><br>