Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393998
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-20
Brief Title:
CO2 Supplement for Treatment of Acute Mountain Sickness
Sponsor:
State Key Laboratory of Respiratory Disease
Organization:
State Key Laboratory of Respiratory Disease
Study Overview
Official Title:
CO2 Supplement for Prophylaxis and Treatment of Acute Mountain Sickness Using Novel Device
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It was reported that up to 76 people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer It has also been well documented that exercise capacity was impaired at high altitude Oxygen inhalation is the most effective treatment method but it is impractical for outdoor activities because of the large volume required There are some drugs such as acetazolamide and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA There is no available device which can accurately supply constant CO2 and is functionally free of dead space We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS
Detailed Description:
Objective To determine whether after rapid ascent to high altitude the device could reduce the incidence and severity of AMS as defined by AMS scores improve sleep quality and reduce central sleep apnea events
Methods A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude 1000m a year before the study Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep Blood gases will be measured 30 minutes after inhalation of air or CO2 SaO2 heart rate and respiratory rate will be recorded every two hours AMS Lake Louise Acute Mountain Sickness Score will be recorded before and after sleep PSG including diaphragm EMG would be recorded under CO2 or air Exercise time ventilation heart rate respiratory rate and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or ambient air
Methods A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude 1000m a year before the study Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep Blood gases will be measured 30 minutes after inhalation of air or CO2 SaO2 heart rate and respiratory rate will be recorded every two hours AMS Lake Louise Acute Mountain Sickness Score will be recorded before and after sleep PSG including diaphragm EMG would be recorded under CO2 or air Exercise time ventilation heart rate respiratory rate and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or ambient air
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None