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Decompression Tables for Diving at Altitude

Primary Purpose

Decompression Sickness, Acute Mountain Sickness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pressure
Breathing Gas
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Decompression Sickness

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altitude Dive Altitude profile

Arm Description

Subjects are exposed to Pressure profiles (Altitude followed by a Dive with a return to Altitude) and Breathing Gases during dive exposures.

Outcomes

Primary Outcome Measures

Decompression Sickness
Subjects will be evaluated for symptoms of decompression sickness when returning to the initial altitude following a dive exposure.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2017
Last Updated
November 30, 2021
Sponsor
Duke University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03390335
Brief Title
Decompression Tables for Diving at Altitude
Official Title
Development of Decompression Tables for Diving at Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Three different types of experiments will be performed: (A). Testing of Cross corrections breathing air at 8,000 (0.743 ATA) and 10,000 ft (0.688 ATA). Subjects will be decompressed in a hypobaric chamber to one of the altitudes above. A no-stop dive to 60 fsw will be tested at each altitude (2.82 ATA at sea level, 2.56 ATA at 8,000 ft, 2.51 ATA at 10,000 ft). Using the Cross corrections, the virtual depth for both altitudes is 90 fsw, for which the no-stop time is 30 minutes. During the dive the subject will be immersed/submersed at rest/mild exercise in 28°C water. Ascent rate will be 30 fsw/min. Upon surfacing the diver will be monitored for 12 hours for symptoms of decompression sickness and transthoracic echocardiography (rest and leg/arm motion) to examine for venous gas embolism (VGE) at 5, 15, 30, 60 and 120 minutes after surfacing. After that, measurements will be continued until no bubbles are detected. (B). Testing of a no-stop dive to 100 fsw at 10,000 ft and 12,000 ft breathing 35% O2. For this series of experiments all subjects will remain at altitude for 48 hours before diving, in order to allow for resolution of AMS symptoms. Appropriate depth-time profiles have been assessed by calculating the equivalent sea level air depth for each of these dives (PN2 values 2.42 and 2.36 ATM, respectively). These yield equivalent air depths of 68 and 66 fsw, respectively. Cross corrected virtual depths would therefore be 99 and 104 fsw, yielding no-stop times of 25 and 20 minutes, respectively. The Cross correction method will be used in this instance because, although largely untested, it is presently in use by the Navy. As with the air dives described above, the more provocative dives (12,000 ft) will be completed before the ones at 10,000 ft, which will increase the confidence for the bottom time used at the lower altitude. (C). Testing to determine whether a high PO2 dive would reverse altitude acclimatization and re-establish susceptibility to AMS. Subjects will ascend in the chamber to 15,000 ft in a graded fashion over 12 hours (15,000 ft has been chosen due to extensive Duke experience with this altitude). Then, after 48 hours they will simulate a hyperoxic dive by breathing 100% O2 for 120 minutes at 1.3 ATA. This will simulate, for example, a 2 hour dive at 12,000 ft to 65 fsw breathing 50% O2. The diver will then return to 15,000 ft and remain at that altitude for 24 hours to allow for AMS symptoms to recur (if indeed they do). Lake Louise AMS scores will be collected every 8 hours. AMS symptoms will be treated with acetaminophen, NSAIDs and anti-emetics as needed. Subjects will be assessed clinically every 12 hours for high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE). Occurrence of either HAPE or HACE will require that the subject be returned immediately to 1 ATA and treated appropriately.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompression Sickness, Acute Mountain Sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This design is a two factor, incomplete block design - three altitudes (8,000, 10,000, and 12,000 feet) and 2 breathing gases (air, 35% O2-N2). The investigators expect to see 0 events in the combinations tested, calculated by the Bayesian Method. If the rate of events is larger than expected, the investigators will use logistic regression to assess if the main effect Air (Air vs. 35% O2-N2) or altitude (8,000, 10,000 or 12,000 feet) or the interaction of these 2 factors imparts relative increased risk. The investigators will set a Type-I error rate of 0.05 (two-tailed).In the presence of 'zero cells', the investigators will either (1) collapse cells into reasonable groups, or (2) add a very small set of constants to the frequency and assess the impact on the effect sizes and tests of significance.1 In the absence of an interaction effect, main effects will be reported.
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Altitude Dive Altitude profile
Arm Type
Experimental
Arm Description
Subjects are exposed to Pressure profiles (Altitude followed by a Dive with a return to Altitude) and Breathing Gases during dive exposures.
Intervention Type
Other
Intervention Name(s)
Pressure
Intervention Description
Subjects undergo altitude exposure, diving exposure, and return to altitude. Altitudes: 8,000, 10,000, 12,000, or 15,000 feet Dives: 60 or 100 feet of sea water
Intervention Type
Other
Intervention Name(s)
Breathing Gas
Intervention Description
Subjects will breathe air, 35% Oxygen, Balance Nitrogen, or 100% Oxygen during the diving exposure
Primary Outcome Measure Information:
Title
Decompression Sickness
Description
Subjects will be evaluated for symptoms of decompression sickness when returning to the initial altitude following a dive exposure.
Time Frame
12 hours
Title
Maximum Acute Mountain Sickness (AMS) Score Change
Description
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.
Time Frame
48 hour, 72 hours
Secondary Outcome Measure Information:
Title
Venous Gas Emboli
Description
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
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Moon, MD
Organizational Affiliation
Duke Universtiy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Decompression Tables for Diving at Altitude

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