Development of a Medical Program for Commercial Spaceflight Aerospace Medicine Grand Rounds May 26, 2015 James M. Vanderploeg, MD, MPH

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1 Development of a Medical Program for Commercial Spaceflight Aerospace Medicine Grand Rounds May 26, 2015 James M. Vanderploeg, MD, MPH

2 Disclaimer Principal Investigator for UTMB and Executive Director of the Center of Excellence for Commercial Space Transportation Chief Medical Officer for Virgin Galactic

3 Objectives 1. Recognize the challenges of enabling a broad range of individuals to safely undertake a spaceflight. 2. Describe the components of a commercial spaceflight medical program. 3. Identify the requirements for emergency medical response for a human commercial spaceflight.

4 Commercial Space Flight Participants Aerospace Medical Association Space Passenger Task Force published two reports in ASEM October 2001 Considered both sub-orbital and orbital SFPs Long list of disqualifying conditions November 2002 Considered only sub-orbital flights Broad guidelines based on certain assumptions

5 AsMA Space Passenger Task Force Report II Summary In summary, the 2 nd Task Force on Space Travel offers only broad guidelines, rather than specifics, for short-duration flights. The application of these guidelines should be left to the discretion of the companies, physicians, and passengers. In cases of passengers with significant illness, sound medical judgment will be essential.

6 FAA Documents March 2003 Guidance for Medical Screening of Commercial Aerospace Passengers February 2005 Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Space Flight Participants February 2005 Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Flight Crew

7 FAA Documents (cont.) December 2005 NPRM: Human Space Flight Requirements for Crew and Space Flight Participants; Proposed Rule January 2006 Guidance for Medical Screening of Commercial Aerospace Passengers (DOT/FAA/AM- 06/1) December 2006 Human Space Flight Requirements for Crew and Space Flight Participants; Final Rule

8 FAA Final Rule Crew Members: Those with a safety-critical role must possess and carry an FAA second-class airman medical certificate Space Flight Participants must: Sign informed consent after education about the risks Sign waiver of claims against the U.S. Government Have training for emergency situations smoke, fire, depressurization, emergency exit Meet security requirement the SFP may not carry on board any explosives, firearms, knives, or other weapons

9 FAA Medical Guidance Jan Categorizes passengers into suborbital and orbital, but the G force definitions associated with each will put some operators passengers into the orbital category for suborbital flights Assumptions: Cabin pressure <= 8,000 feet G level limits: +4 G z, -2 G z, +/- 4 G x, +/- 1 G y Recommendations for medical history and pre-flight physical exam

10 Recommendations from COE CST Research Task Differentiated by Suborbital versus Orbital and Spaceflight Participants versus Pilots. Take into account the flight profile. Medical screening questionnaires and pre-flight medical exams. Evaluations by physicians trained in aerospace medicine. Employ risk mitigation strategies. Provide appropriate pre-flight training. Available on COE CST website at: UTMB%20Final%20Report.pdf

11 What are some of the challenges? Passengers Wide age range (18 to 90 s) Multiple medical conditions Located around the globe Lack of data for making selection decisions Need for appropriate training High Volume of Passengers Frequent Flights for Crewmembers Remote Location of Spaceports

12 Virgin Galactic Customers The customers form a diverse pool World wide representation: from 57 countries to date Men (80%) & women (20%) (current age restriction: 18 and older) Some are flying as individuals, some as couples Some are flying as families Many different cultures and backgrounds Many customers are high net worth individuals Some are celebrities All have a passion for spaceflight

13 Where are the customers? 57 Countries Top 5 are: United States: 34% United Kingdom/Ireland: 15% Australia/New Zealand: 6% Canada: 5% Russia: 5%

14 Factors Affecting Medical Considerations Acceleration Launch: +3.5 G x and +3.5 G z Re-entry: +6 G x Cabin pressurization 5,000 to 8,000 feet On board medical capability very limited during the spaceflight itself Cardiovascular, Pulmonary, Psychological, Neurological, Musculoskeletal, and other concerns

15 Other Considerations Pregnancy How do you (can you) protect the fetus? Children Can parents give informed consent for their children

16 The Virgin Galactic Medical Program Each customer flies at their own risk US FAA regulations require each SPF to receive and sign an Informed Consent prior to flight Safety is at the heart of the VG organization Safety through vehicle design Safety through operation Safety through preparation of our customers Optimal preparation not only protects their safety but also maximizes the opportunity for enjoyment of the spaceflight experience For the individual customer And for the group

17 Overview of Customer Group Over 700 Ticket holders Currently, approximately half have submitted Medical History Questionnaires Some have provided significant amounts of data Medical Records Imaging reports Medical History documentation Others have given us only minimal information

18 What kind of medical problems do they have? High blood pressure Neck, back, and extremity problems Heart disease Bypass surgery Stents Implanted pacemakers Pulmonary disease Diabetes (w insulin pump) High cholesterol Cancer Psychiatric or psychological problems

19 Medical Decision Making How do we identify concerning medical conditions? Novel field, most of these diseases have NEVER flown before Concerns: How to screen/train/monitor Medical problem arising during dynamic phases of flight Space environment exacerbating medical condition

20 Initial Studies Initial data collected during Virgin Galactic Founders training centrifuge runs NASTAR centrifuge, Southampton, PA 77 participants, voluntarily offered data for analysis Pre/post-spin BP Continuous HR 16 subjects with PO 2

21 NASTAR Center

22 Results

23 Results SFPs successfully completed centrifuge training with little difficulty Additional medical testing or records: Did not preclude anyone from participating Not predictive of participant performance Past medical history NOT associated with difference in tolerance No significant cardiac, cerebrovascular, respiratory events Cardiovascular response attenuated in older participants NOT associated with change in tolerance Most individuals likely able to tolerate?

24 University Research Studies (conducted by UTMB at the NASTAR Center) Purpose: To evaluate subjects with defined disease states under the G-loads expected during commercial spaceflight using centrifuge-induced acceleration Disease cohorts: Cardiovascular disease Hypertension Diabetes Pulmonary Disease Spinal Disease or Injury

25 Methods Seven centrifuge runs over 2 days: Day 1: Two +Gz runs (Peak +3.5Gz, Run 2) Two +Gx runs (Peak +6Gx, Run 2) Day 2: 3 runs approximating suborbital spaceflight profiles Combined +Gx and +Gz Peak +6.0Gx/+4.0Gz/R+6.1G

26 NASTAR Center Training Profiles

27 NASTAR Center Training Profiles

28 Methods Data collected included: Blood Pressure Electrocardiogram Pulse oximetry Neurovestibular exams Post-run questionnaires regarding: Motion sickness, disorientation, greyout, anxiety, other symptoms

29 Conclusions Overall: The majority of individuals with WELL CONTROLLED medical conditions appear to be able to tolerate the acceleration profiles of launch/landing of commercial spaceflight Anxiety may be an issue Mitigation strategies for common problems (anxiety, ineffective AGSM) should be considered

30 How do our customers impact operations? Training Care and feeding Seat design and fit Restraint design Egress nominal & emergency Speed of response Language barriers

31 Components of Medical Program Online Medical Questionnaire Review Risk estimate Additional Information Review Risk estimate AME Exam Review Acceptance for Flight Mitigation of Risk Acceptance of Risk Additional Testing Classification of Risk Ongoing review and updates Preflight Training Space Flight Post-flight Medical Debrief

32 Virgin Galactic Medical Program Electronic Health Record System Involve aerospace medicine specialists around the world Basic medical evaluation with augmentation as indicated

33 Detailed Medical Questionnaire

34 Evaluating Medical Risk Initial risk assessment Subjectively identified as low-medium-high Given green, yellow, red coding Reevaluated with further information: Cardiovascular Blood pressure Musculoskeletal Exercise Diabetes Pulmonary Overall

35 Evaluating Medical Risks - Graded by two evaluators green, yellow, red per category - Cumulative score given on a 1-10 scale 1-4 Green (could fly without trouble) 5-7 Yellow (need more evaluation before flight) 8-10 Red (would have difficulty tolerating flight)

36 Medical Screening Flow Online Medical Questionnaire Review Risk estimate Additional Information Review Risk estimate AME Exam Review Acceptance for Flight Mitigation of Risk Acceptance of Risk Additional Testing Classification of Risk Ongoing review and updates Preflight Training Space Flight Post-flight Medical Debrief

37 Emergency Medical Response Highly trained on scene medical team Emergency medical transport

38 Spaceport America Remote location Rough terrain Limited access Air medevac will be necessary Definitive medical care is a long way away

39 Emergency Medical Response In-house capabilities for planning and oversight roles Coordinate with Spaceport fire/crash/rescue capabilities Establish air and ground medevac capabilities Engage local and regional medical communities Augment on-site capabilities with additional EMS and emergency medicine trained physicians on flight days Practice, practice, practice. Plan for the worst / expect the best

40 Questions?

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