Acute Mountain Sickness Clinical Trial
Official title:
Development of Decompression Tables for Diving at Altitude
Verified date | November 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aims of this proposal are to test current USN procedures for adjusting decompression procedures during air diving at 8,000 and 10,000 ft altitude and to provide a decompression algorithm for no-stop dives to 100 feet of sea water (fsw) at 10,000 and 12,000 ft altitude using enriched O2 (PO2=1.3 ATM). Additionally, the experiments will determine whether a period of hyperbaric hyperoxia, such as would be experienced during a dive at altitude, reverses altitude acclimatization, resulting in a return of acute mountain sickness (AMS) symptoms.
Status | Completed |
Enrollment | 103 |
Est. completion date | October 29, 2021 |
Est. primary completion date | October 29, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Exclusion Criteria: - smoking, cardiorespiratory disease (including hypertension, airways obstruction), seizure disorder, pregnancy, history of middle ear or sinus disease or high altitude cerebral or pulmonary edema (HACE, HAPE), inability to perform middle ear autoinflation, anemia, sickle cell disease and sickle cell trait. Individuals with VO2peak <35 mL.kg-1.min-1 (males) and <30 mL.kg-1.min-1 (females) |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decompression Sickness | Subjects will be evaluated for symptoms of decompression sickness when returning to the initial altitude following a dive exposure. | 12 hours | |
Primary | Maximum Acute Mountain Sickness (AMS) Score Change | Lake Louise Scoring System for Acute Mountain Sickness. Subjects will fill out a six-question questionnaire (0 - 3, higher scores are worse symptoms) and a three-question clinical assessment (0-4, 0-4, 0-2, higher score is worse a assessment). The total score of all questions and assessments (0 - 28, higher is worse AMS), is determined every eight hours for 48 hours at altitude pre-dive and 24 hours at altitude post-dive. | 48 hour, 72 hours | |
Secondary | Venous Gas Emboli | 2D ultrasound will be used to assess right ventricular bubble score at 5, 15, 30, 60 and 120 minutes and hourly until no bubbles are detected using the following scale: Modified Eftedal-Brubakk Scale for Venous Gas Embolism (VGE)
Grade Definition 0 No observable bubbles Occasional bubbles At least 1 bubble every 4 heart cycles At least 1 bubble every heart cycle A Continuous bubbling, 1-2 bubbles per cm2 in every image 4B Continuous bubbling, at least 3 bubbles per cm2 in every image 4C Almost complete whiteout in the right heart, individual bubbles can still be discerned 5 "White out", single bubbles cannot be discriminated |
12 hours |
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