SATPC0040030 Tab 04 4 SOW.pdf

Hypobaric Chamber Services Statement of Work (SOW) Exercise during Prebreathe Test Protocol

This statement of work defines the use of an individual altitude chamber(s) for the execution of the prospective hypobaric testing needed to support the development of a decompression sickness (DCS) risk estimation tool, the Aerospace Estimation Tool for Hypobaric Exposure Risk (AETHER), led by NASA Johnson Space Center (JSC). Specifically, this SOW addresses the execution of data collection to investigate the effect(s) of exercise during prebreathe prior to the performance of a simulated EVA as a mitigation strategy for DCS. The NASA-defined study protocol is described in detail below. This procurement is for recruitment, data collection, and data delivery for six (6) subjects participating in the control and two experimental conditions (or test days).

The results of these tests will inform requirements for future space vehicles, habitats, suits, and mission planning. NASA’s own facilities also will support this work in part, but those facilities are shared with other programs, limiting the overall availability of NASA facilities. Use of non- NASA resources to support these objectives are important to facilitating timely development and implementation of safe and successful prebreathe procedures during extravehicular activities (EVAs) in weightlessness and in partial gravity during Exploration missions. NASA’s main objective in engaging other facilities is to support an increased tempo of data collection to develop a comprehensive model of altitude physiology (focused on DCS risk) during missions across a range of conditions.

Facilities are requested to perform single day chamber-based tests as defined by NASA and deliver data (including but not limited to raw and processed data, images, video) to NASA.

NASA will perform the analysis of these data. Also, data collection will include assessing subjects for patent foramen ovale (PFO) for which details are described below. NASA will coordinate planning meetings and training for protocols, as needed. NASA will attend tests as necessary to verify correct implementation and conduct of protocols.

Organizations conducting these chamber tests will have completed pilot chamber tests to demonstrate their capabilities to and have their test data reviewed by NASA. Chambers selected for the tests described in the current Statement of Work will have documented and verified resolution of any deficiencies identified in their execution of NASA-defined DCS pilot test protocols.

Budget for this work is firm fixed price. Budget quotes can include payments for interim milestone completion. Dates for each interim milestone should be set by the vendor.

Subjects Facilities will recruit and screen applicants to provide at least 3 subjects per chamber test day.

Screening, training and availability of at least 1 back-up subject per test day is required in case of subject availability issues, withdrawal, or disqualification. Facilities should recruit and screen subjects per their standard procedures. NASA will provide inclusion and exclusion criteria to recruit a sample of subjects with similar demographics to the NASA astronaut corps. For this procurement of 6 subjects, at least two participants to complete all three conditions shall be female, though a 50-50 male-female split is preferred, if possible, to account for sex effects.

Subjects must complete peak aerobic capacity (VO2pk) testing with metabolic gas analysis as part of the subject screening. NASA will provide the VO2pk test protocols, but facilities will be responsible for conducting the test. Metabolic gas analysis hardware may be loaned to the facility by NASA upon request for the duration of this work, if necessary.

Following the screening and qualification for study participation, candidate subjects (including back-up subjects) will participate in an informed consent briefing during which they will receive verbal and written descriptions of the test protocol, be encouraged to ask questions, and will provide written consent before proceeding to participation in the testing. Thereafter, subjects will be trained and familiarized with the chamber protocol and safety procedures, and how to safely use the oxygen mask. Subjects also will be familiarized with the EVA simulation workstations and associated workloads (submaximal exercise intensity, 25-80% VO2pk).

Individual workload at each station will be determined and verified by metabolic rate measurements using a portable metabolic gas analysis system to ensure that cadence and work rates meet in-chamber exercise task requirements. Subjects who have participated in an acceptable previous familiarization session within the last 6 months will not have to repeat this session with NASA approval.

Test conditions will include one control and two experimental prebreathe protocols. This is a cross-over testing design; each test subject should agree to perform the control condition and the two experimental conditions. The order of the test conditions should be randomized within subjects and counterbalanced across subjects. Within a subject, all three decompression trials should be completed within 1 year of the Peak Cycle test, and all three decompression trials should be completed within 6 months (time between the first and third test day).

Test Plan In all conditions, subjects report to the facility in the morning and be briefed on the test conditions to which they will be exposed that day. Thereafter, subjects will be fitted with an oxygen delivery system with breathing mask, complete the prebreathe condition for that day, and then complete a simulation of EVA lasting 6 hours, or until signs or symptoms that require test termination (per NASA and facility standards), test termination by subject request, or facility or monitoring capabilities malfunctions.

Table 1. Control and experimental conditions. Descriptions provided below.

Prebreathe EVA Test

Condition Duration* Inspired

Gas Ambient Pressure Exercise Duration

Inspired Gas

Ambient Pressure

Control 1 hour 100% O2 14.7 psia None 6 hours 100% O2 6.2 psia Low

Exercise 1 hour 100% O2 14.7 psia 25% VO2pk 6 hours 100% O2 6.2 psia Moderate Exercise 1 hour 100% O2 14.7 psia 40% VO2pk 6 hours 100% O2 6.2 psia

NOTE: Within a subject, consecutive test days should be separated by at least 72 hours.

NOTE: Chamber pressure shall be maintained with +/- 0.1 psi of nominal pressure specified.

*Prebreathe duration may be increased on NASA direction, (up to an additional 2 hours; total prebreathe time not to exceed 3 hrs.) if excessive DCS burden is observed.

Medical Monitoring The facility will provide the appropriate medical support to perform physical examinations before ingress, during the protocol, for treatment and management of subjects as needed, to support clearance of subjects after the protocol is completed, and to follow-up in the days after the chamber run. Responsibilities of the medical personnel include monitoring and interpretation of 2-D ultrasound imaging for VGE as well as monitoring of the subject’s self-report and symptoms of DCS or intolerance.

Pre-EVA Conditions Facilities will have the capability for continuous habitation of the chamber from the ingress through the performance of prebreathe and simulated EVA. Subjects will begin oxygen breathing at the start of the prebreathe and remain on oxygen throughout decompression and repressurization. all subjects should start prebreathe within a 10-second period. NASA may provide the breathing masks and/or will review and provide approvals for suitable substitutions. During prebreathe and cabin depress, subjects should be provided fluids ad libitum using a drink port (or NASA-approved alternative) without a break in prebreathe.

Subjects should not eat during the prebreathe or the EVA. Subjects are not allowed to sleep during the test, including the prebreathe, EVA, and post-run medical clearance.

EVA Simulation Subjects will perform a simulated 6-hour EVA with NASA-defined standardized monitoring. To simulate the suit environment, the chamber will be depressurized using the NASA-provided pressure profile before initiating the EVA simulation tasks described below. The start time of the EVA is defined by the start of decompression, and the end time of the EVA is defined by the start of repressurization.

EVA simulations will include rotation of each subject through a repetitive series of tasks at predetermined intervals in a pre-determined order, as defined by NASA. The intensity of the physical work will be prescribed by protocol-defined work rates and duration. The EVA is simulated using eight different stations, nominally performed in 2 sets of 4 stations, with subjects rotating between stations every 5 minutes. Design of the workstations will be provided by NASA.

Subjects will rotate through three stations that simulate vigorous EVA-like activities across various muscle groups followed by a ‘rest’ stage for an echocardiogram to grade venous gas emboli. They then follow with three different exercise stations followed by another echocardiogram ‘rest’ stage, with each cycle of 8 stations lasting 40 minutes. Thus, in each cycle subjects will perform 15 minutes of low- to moderate-intensity exercise followed by 5 minutes of monitoring (see sections below) and rest. Work rates during arm ergometry (cadence and resistance) and stepping (cadence) will be prescribed based upon the results of the VO2pk test and the pre-test EVA simulation familiarization with metabolic gas analysis.

During ultrasound imaging, at least 10 cardiac cycles will be monitored and recorded in each of three conditions in sequential order: rest, flexing/bending of each limb, and rest. Compliance of the subjects with the prescribed procedures should be documented, including symptoms reported by the subjects and test operator observations.

Standardized Measures Facilities will document subject demographics, including sex, age, height, weight, and body composition estimated by skinfold measurements. Facilities will use a standardized set of measurements to monitor and document test subject responses during the prebreathe, decompression, and recompression. NASA will provide the specific measures, preferred method for collection, and timeline for data recording and subject reporting.

Logging of symptoms and definition of DCS Test operators (including medical support team) will record all medical symptoms reported by the test subjects throughout the duration of the protocol, in response to prompting by the test operators and spontaneous self-reporting. Subjects will be removed from the chamber and repressurized (airlock or chamber) if they exhibit any symptoms concerning for DCS (Type I or Type II), or if bubbles are observed in the left ventricle (LVGE), regardless of whether they are symptomatic.

Questionnaires Test operators will query subjects for responses to standardized questionnaires during each rotation through the resting/ultrasound station. Subjects will report a rating of perceived exertion (RPE), pain, and mask comfort using NASA-defined scales at the end of cycle of EVA simulation (i.e., every 40 minutes). Reporting will require less than 1 minute for subject responses and recording by the test operator(s). Subjects also will be asked to complete a NASA-provided mask utility survey at the end of each decompression trial test day. This survey will take less than 5 minutes to complete.

Ultrasound Echocardiograms for detection of VGE will be performed by a qualified test operator during each rotation through the resting/ultrasound station while the subject is at rest and following exercise. Echocardiograms will be recorded and stored electronically with relevant metadata (e.g., subject ID) for post-exposure review and analysis. Ultrasound imaging will be scored in real-time using the modified Eftedal-Brubbak (EB) scale (0-7) [1]. Each scan within the entire data set must be graded by at least 3 different individuals (up to two can be post-hoc), and both the individual and median of the 3 scores shall be documented.

Patent Foramen Ovale (PFO) Assessment Facilities should arrange for transthoracic ultrasound imaging with contrast (agitated saline), or equivalent, to test for the presence and severity of a PFO using standard procedures and scoring as defined, or approved, by NASA.

PFO assessment should not be used as a tool to exclude subject participation to avoid biased selection of the subject pool or prospectively to influence decisions regarding interpretation of subject symptoms or test termination. PFO currently is not used as exclusion criteria for astronauts to perform EVA, and its use for exclusion or test termination would not be representative of current NASA medical practices. If PFO image acquisition or assessment is performed prior to a chamber test, then test operators should be blinded to the results.

Imaging for and local interpretation of PFO assessments shall be shared with NASA for inclusion in DCS modeling activities relevant to the AETHER project. Test results may be shared with the subject at their request or if the PFO assessment reveals clinical concerns; however, this may preclude this subject’s participation in future testing and diving activities. Thus, disclosure should occur with a qualified individual with expertise in the prognostic value and implications of PFO to discuss the findings and answer any of the subject’s questions. Thereafter, the subject should be encouraged to consult their personal physician. The facility should make the imaging and results of the PFO screening available to the subject to share with their physician for follow-up.

Additional Measures Facilities may perform additional data collection for IRB-approved studies on a non-interference basis with NASA approval. Approval for the additional measures from the facility’s IRB is the responsibility of the facility. If necessary, NASA will obtain IRB approval from the NASA IRB using a multi-site protocol. Results from these data collections will be shared with NASA for archiving. For example, if blood or urine samples are collected by the facility for uses other than the standard data collection as defined above, the results of these assays will be shared with NASA. If blood or urine samples are collected by the facility, these results also should be blinded to the subject and the test operators until after the completion of the test, unless the results indicate a significant clinical concern. NASA will not be responsible for any costs directly related to obtaining and reporting these additional measures.

Test Plan Verification and Training NASA will meet with each facility to discuss the test plan before submission of required documents to the facility’s governing IRB and to verify expectations of the chamber runs, schedule, data delivery, and reporting of off-nominal events or outcomes. NASA will meet with each facility to conduct test readiness review as appropriate per facility and/or NASA guidelines. NASA may attend and monitor chamber runs to answer questions in real-time and recommend changes to the procedures.

Data Delivery and Validation At the conclusion of each test run, the facility will deliver electronic records to NASA using a secure, NASA-approved method within 14 days. The data package will include subject metadata, console and/or operator’s logs (including chamber event time, prebreathe records, EVA time, EVA station schedule), continuous recording of chamber pressure for the entire chamber run (demonstrating depress and repress rates as well as sustained chamber pressure), chamber environmental conditions (partial pressures of O2 and CO2, temperature, humidity), questionnaires, medical monitoring logs, ultrasound recordings and VGE scores, in-chamber video of EVA workstations, audio logs, hardware and chamber setup, procedures, and DCS case descriptions using the NASA-provided reporting format. Each facility will have ultrasound images of VGE scored by at least 3 reviewers in a blinded fashion. NASA will provide a template for the documentation of these. NASA will review the data set for each chamber run within 15- 30 days of receipt. Detailed statistical analysis and modeling will be performed by NASA.

Unexpected results and incidents should be reported to NASA within 12 hours of the event.

These include facility-related anomalies and subject specific events. In accordance with NASA guidelines for NASA-funded work, this information must be reported to NASA management and safety officers within 24 hours of the event. The facility will contact the NASA-designated point of contact (POC) for this work, and the NASA-designated POC will coordinate the reporting to NASA management. NASA will request follow-up information and/or documentation, as needed. If a facility-related incident, NASA will require a corrective action plan and verification before proceeding to subsequent chamber tests.

NASA will coordinate regular meetings with the facility (approximately once every two weeks) to discuss project status, feedback to or from the facility, data delivery, and/or problem resolution strategy.

Facilities participating in this procurement need to have previously successfully completed the NASA chamber pilot protocol and need to be proficient in the following per NASA standard or with NASA accepted mitigation plan:

• EVA data collection and operation including EVA task simulation and workload calibration, medical logging, VGE data collection and grading; and

• Subject screening, training and demographic data collection; and

• Chamber data collection and operation including environmental profile, and audio/video recording; and

• Operation of loaner equipment.

Facilities participating in this procurement need to be proficient in the following or include the costs for training in their proposal budget:

• Mask operating procedures: required if facility has not completed this training previously with Phantom Plus mask. The facility should budget for 2 days of training at mask vendor site or at their facility with vendor. Training should be procured by the facility from manufacturer-approved experts. To arrange and inquire regarding costs for training, please contact the EATON training team (contact details available from NASA upon request).

• Dangerous goods shipping personnel certification (optional): If NASA loans the K5 metabolic gas analysis system to the facility, some shipping vendors may designate the COSMED laptop battery as “dangerous goods”.

Required Hardware A detailed list of hardware and consumables is shown below. Upon request and based upon availability, some hardware may be available to loan to the facility for the execution of this work, as detailed below. All loaner hardware shall be returned to NASA upon request in the original condition, unless otherwise specified and agreed upon by NASA. If the facility has these specific items or comparable items approved by NASA (e.g., portable metabolic cart, ultrasound), the facility’s budget should include purchase of the consumables. Facilities participating in this procurement are responsible for procurement of all hardware and equipment outside of that loaned by NASA. Additionally, the facility is responsible for calibration of all hardware per vendor recommendations and/or NASA-specific requirements.

Equipment designated as “dangerous goods” for shipping by NASA in compliance with Hazardous Material Regulations (https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C) will be procured by the chambers directly. NASA recommends, but does not require, that the facilities have certified personnel for packing and shipment “dangerous goods” (air and ground).

Note: The COSMED loaner laptop built-in battery might be considered as “dangerous goods” by some freight carriers.

Table 2. Required Hardware for Protocol

Item(s) Quantity Notes These items may be loaned by NASA pending availability

Gentex Phantom + (POM+) oxygen masks with drink port

6-10

• Number of masks required depends upon number of subjects and operator per run and schedule.

• Loan by NASA can be arranged.

• Training should be procured by the facility from manufacturer-approved experts Gentex Phantom Mask Toolkit

1 • Loan by NASA can be arranged.

• Training should be procured by the facility from manufacturer-approved experts https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C

GE Vivid iQ Ultrasound & 3Sc-RS probe (or NASA-approved equivalent)

1 • Loan by NASA can be arranged.

• Protocol-specific imaging training was provided by NASA during chamber pilot study. Chamber is responsible for additional training to maintain proficiency and/or train new operators. NASA will provide additional training if data collection protocols are modified by NASA.

COSMED K5 Portable Metabolic Gas Analysis System (or NASA-approved equivalent)

1 • Includes mask, K5 parts, and laptop

• Loan by NASA can be arranged

• Protocol-specific imaging training was provided by NASA during chamber pilot study. Chamber is responsible for additional training to maintain proficiency and/or train new operators. NASA will provide additional training if data collection protocols are modified by NASA.

Chamber is responsible for providing these items Decompression Chamber and supporting hardware

As Required

• Facility responsible items. Including chamber functional and monitoring hardware for safe and effective operations, communication system, audio/video system, medical, toilet, trash can, etc.

EVA Workstation 1 system • Hardware consistent with NASA requirement, includes step station, arm ergometer, patient cot, umbilical management system, batteries for metronome (AAA), and peripherals.

• Requirements, CAD diagram, and parts lists are provided by NASA as needed.

Ultrasound station

1 • Including ultrasound stand, HDMI cables or other video/audio recording methods, surgical markers, hardware drive, US gel, wipes

VO2 Peak Testing Station

1 • Facility responsible item. Includes ECG*, metabolic cart*, and cycle ergometer (e.g., Lode Bike that can connect to metabolic cart).

• NASA will provide protocol and acceptable data record template.

Subject supplies As Required

• Facility responsible items, including clothing, hydration fluids (including container), toiletry/hygiene, handheld mirrors, skin fold calipers (per NASA protocol and data record template).

Mask (POM+) Integration

As required • Facility responsible item, including but not limited to hydration canteen/connector, O2 supply system, mask harness, mask sizing caliper, and communication system.

• NASA will provide protocol and recommendations.

Mask (POM+) Cleaning

Supplies As

Required

• Facility responsible items.

• NASA will provide standard operating procedure and list of approved supplies.

Heart rate sensor batteries

(or as required)

• Facility responsible items.

• CR2025 Coin Battery, 1 in use, 1 for back-up

• For use during workload calibration sessions.

Other testing supplies As Required

• Other miscellaneous items required for the safe and effective execution of this work

COSMED calibration gas tank and cart

1 • Facility responsible items. (Classified as “dangerous goods”)

• Calibration gas mix CGA-973 (16% O2, 5%CO2, N2 balance)

• Includes gas tank cart-trolley

• Verify expiration date per use

• COSMED P/Ns: Cart, A-860-900-003; Gas, A-860-000-

004) COSMED Sensor Kit 1 • Facility responsible items. (Classified as “dangerous goods”)

• Expires quickly. Facility shall ensure an unexpired kit is available in their facility throughout the project.

• COSMED P/N: C04391-01-11

COSMED K5 battery 2 • Facility responsible items. (Classified as “dangerous goods”)

• 1 primary and 1 backup

• COSMED P/N: C04273-01-05.

* Facility can use other ECG and metabolic cart systems to generates data that meet NASA protocol and data delivery requirements. The accuracy of the metabolic gas analysis system should have been validated in the facility’s laboratory or in a published study.

NASA will facilitate regular preventive maintenance on some hardware (e.g., ultrasound) which will require temporary return of the hardware or visit by the vendor-provided preventive maintenance technicians to the facility to which the hardware is loaned. Facilities that have received loaner hardware will make the hardware available for preventive maintenance and/or arrange for shipping to NASA for this purpose. Further, upon request by NASA, facilities using NASA-loaned hardware will assist in the inventory (e.g., photographic documentation) for NASA purposes.

Summary For the protocol listed in Table 1, provide the following for 6 subjects in each of those test conditions.

1. Estimated schedule for completing data collection

2. Budgets should include total budget plus breakdown of incremental payments including the milestones/schedule associated with those incremental payments.

REFERENCES

1. Eftedal O, Brubakk AO. Agreement between trained and untrained observers in grading intravascular bubble signals in ultrasonic images. Undersea Hyperb Med 24: 29299, 1997.

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