Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT03390335
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2017-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decompression Tables for Diving at Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003665', 'term': 'Decompression Sickness'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D001469', 'term': 'Barotrauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011312', 'term': 'Pressure'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2017-12-28', 'studyFirstSubmitQcDate': '2017-12-28', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decompression Sickness', 'timeFrame': '12 hours', 'description': 'Subjects will be evaluated for symptoms of decompression sickness when returning to the initial altitude following a dive exposure.'}, {'measure': 'Maximum Acute Mountain Sickness (AMS) Score Change', 'timeFrame': '48 hour, 72 hours', '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.'}], 'secondaryOutcomes': [{'measure': 'Venous Gas Emboli', 'timeFrame': '12 hours', '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)\n\nGrade Definition 0 No observable bubbles\n\n1. Occasional bubbles\n2. At least 1 bubble every 4 heart cycles\n3. At least 1 bubble every heart cycle\n4. A Continuous bubbling, 1-2 bubbles per cm2 in every image\n\n4B 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decompression Sickness', 'Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Three different types of experiments will be performed:\n\n(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.\n\n(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.\n\n(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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* 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)'}, 'identificationModule': {'nctId': 'NCT03390335', 'briefTitle': 'Decompression Tables for Diving at Altitude', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Development of Decompression Tables for Diving at Altitude', 'orgStudyIdInfo': {'id': 'Pro00087803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Altitude Dive Altitude profile', 'description': 'Subjects are exposed to Pressure profiles (Altitude followed by a Dive with a return to Altitude) and Breathing Gases during dive exposures.', 'interventionNames': ['Other: Pressure', 'Other: Breathing Gas']}], 'interventions': [{'name': 'Pressure', 'type': 'OTHER', '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', 'armGroupLabels': ['Altitude Dive Altitude profile']}, {'name': 'Breathing Gas', 'type': 'OTHER', 'description': 'Subjects will breathe air, 35% Oxygen, Balance Nitrogen, or 100% Oxygen during the diving exposure', 'armGroupLabels': ['Altitude Dive Altitude profile']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Richard Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Universtiy Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}