The primary objective is to determine whether tactile breathing guidance is effective in increasing SpO2 while engaged in a cognitive task during exposure to hypobaric hypoxia.The secondary objectives are:1. Determine whether a difference in SpO2…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Oxygen shortage in body tissue
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The SpO2 (%) differences between natural breathing and guided slow and deep
breathing at 15,000 ft, measured while engaged in a cognitive task.
Secondary outcome
1. The SpO2 level that will be measured while pilots are at rest while
breathing naturally, as well as during guided slow and deep breathing at 15,000
ft.
2. The physiological parameters heart rate (HR), End-tidal CO2 (EtCO2),
End-tidal O2 (EtO2), respiratory frequency (RF), tidal volume (VT) and minute
ventilation (VE) are continuous variables. These parameters will be monitored
during each of the breathing conditions and compared between the two breathing
conditions.
3. The ability of the pilots to follow the tactile breathing guidance while
engaged in a cognitive task will be assessed by comparing respiratory frequency
values measured at rest and during the execution of a cognitive task.
4. Self*perceived state of alertness: the Stanford Sleepiness Scale (SSS) is a
self-rating 7 point scale (1 to 7) used to assess how alert a person is
feeling. Analysis of the data will be performed to discover if a significant
difference in alertness exist between: 1. the start and end of each of the
breathing conditions, 2. the start and end between breathing conditions.
5. A short questionnaire will be given at the end of each breathing session.
The questionnaire at the end of the session will ask the pilots to mark their
hypoxia symptoms out of a list. The questionnaire after the slow and deep
breathing will also contain questions regarding how useable the tactile
breahting guidance is. The pilots will be asked about the strength of the
signal, how intuitive was the signal pattern. The questions will be answered by
placing a vertical line on a 10cm VAS scale.
Background summary
The brain is dependent on oxygen in order to maintain normal function. Oxygen
deficit as a result of exposure to hypoxia has been shown to effect pilot
performance. Slow and deep breathing could help military aircrew increase their
SpO2 and reduce the effects of hypoxia. However, the aircrew is not always
aware of becoming hypoxic and might not start using the technique on time.
Therefore, an external stimuli could be given to the aircrew to guide slow and
deep breathing. The sense of touch might be used to guide slow and deep
breathing.
Study objective
The primary objective is to determine whether tactile breathing guidance is
effective in increasing SpO2 while engaged in a cognitive task during exposure
to hypobaric hypoxia.
The secondary objectives are:
1. Determine whether a difference in SpO2 exists in the following conditions:
between the two breathing conditions when the pilots are at rest and within
breathing condition between rest and cognitive task.
2. Determine the changes in the following physiological variables between the
two breathing conditions: end-tidal CO2 (ETCO2) and O2 (ETO2), minute
ventilation (VE), heart rate (HR), respiratory frequency (RF) and tidal volume
(VT).
3. Determine whether tactile breathing guidance can be followed even when the
pilots engaged in a cognitive task.
4. Determine the changes in alertness levels of the pilots between both
breathing conditions.
5. Evaluate the usability of tactile breathing guidance.
Study design
This study will be a repeated measures design.
The independent variable is guided slow and deep breathing and the dependent
variable is SpO2.
The two levels of breathing condition are: 1. natural breathing and 2. guided
slow and deep breathing.
Intervention
The pilots will be exposed to a simulated altitude of 15,000 ft (4572 m) in a
hypobaric chamber. During a single exposure, the pilots will perform two
different breathing conditions: 1. natural breathing, and 2. guided slow and
deep breathing while engaged in cognitive task.
Study burden and risks
We expect the risks for the pilots in the study to be very small. It is
expected that during exposure to the 15,000 ft. altitude the pilots will
experience hypoxia related symptoms. However, as observed in hypobaric chamber
training performed at this altitude the symptoms vanish after descent is
complete and the pilots start breathing ambient air.In addition, pilots of
RNLAF receive hypoxia training every five years. Therefore, they are familiar
with the symptoms of hypoxia. In addition the pilots will not be exposed to
extreme altitudes or additional risks compared to the normal hypoxia training
they follow during their flight career.
Each pilot will spend a total of two hours, in one day, participating in this
study. This includes familiarization and test session. Four times during the
tset session the pilots will fill in a short questionnaire contaning questions
regarding their alertness (SSS), hypoxia symptoms and the usability of the
tactile breathing guidance.
Kampweg 53
Soesterberg 3769DE
NL
Kampweg 53
Soesterberg 3769DE
NL
Listed location countries
Age
Inclusion criteria
Pilots of the Royal Netherlands Air Force
Male
Age 22-55
The pilots need to pass their mandatory medical examination and be declaered
"fit to fly
Exclusion criteria
Pilots who stayed at altitudes higher than 8000 ft (2438m) for a duration
longer than seven days consecutively three months before they start this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81837.018.22 |