Effect of tactile breathing guidance on oxygen saturation during exposure to hypoxia

Effect of tactile breathing guidance on oxygen saturation during exposure to hypoxia - Tactile breathing guidance during exposure to hypoxia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51648

Enrollment

Registered

2022-12-06

Start date

2023-01-10

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxygen shortage in body tissue hypobaric hypoxia Reduction in blood oxygen saturation (SpO2)

Interventions

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 brea

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The SpO2 (%) differences between natural breathing and guided slow and deep breathing at 15,000 ft, measured while engaged in a cognitive task.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)