This proposal enhanced the collaboration of an international team of experts (Russia/USA) in conducting ground, simulated microgravity, and flight experiments to answer three specific aims:

1. Evaluate the vascular and cardiac effects of the Bracelet-M device in ground based studies using ultrasound in combination with the current system of device calibration, user training, and application.

2. Investigate the human factors, level of experience, and training necessary to perform focused vascular and echocardiography exams in a ground and microgravity environment using real-time remote guidance of inexperienced ultrasound operators.

3. Determine the physiologic effects of the Bracelet-M device on the cardiovascular system during simulated microgravity and flight experiment with recommendations for optimal use protocols with a predictable effect and an increased margin of safety.

Ultrasound is a terrestrial standard of care for assessing cardiovascular function. This proposal developed just-in-time training methodologies, combined with remote guidance, to allow non-expert operators to use ultrasound to evaluate the cardiovascular system and the effects of the Bracelet device on venous loading, vascular capacitance and cardiac performance. This proposal provided essential medical information and capabilities to facilitate exploration class missions. Specifically this proposal developed and validated procedures for the expanded diagnostic use of ultrasound for cardiovascular medical conditions which may occur on the International Space Station and future exploration class missions.

Two primary objectives of this proposal were to obtain baseline information regarding the use of ultrasound to monitor cardiovascular alterations which occur during microgravity exposure and to evaluate the physiologic effects of the Bracelet device. The experimental team developed a rapid training program to allow minimally trained operators to obtain high quality ultrasound images of the cardiac and vascular system, with or without maneuvers to assess the effects of the Braslet device on the vascular system. There was a significant and profound effect of Braslet occlusion on the peripheral and vascular system which caused alterations in cardiac function. This countermeasure device may have therapeutic potential for space adaptation, treatment of vascular disorders in a microgravity environment, and potentially to improve readaptation to a gravity environment.

We have interviewed numerous long duration crewmembers for the optimal human interface for the just-in-time training software for this program. We have conducted 20 baseline examinations with and without the Bracelet device on normal volunteers and optimizing a custom pressure monitoring device for calibration in conjunction with standard methodologies. We have developed a comprehensive methodology, in conjunction with SDTO activities on orbit, to allow non-expert operators to reproducibly conduct cardiac and vascular examinations with or without thigh occlusion devices. We have reliably characterized the profound cardiac, vascular, and optic nerve sheath changes with 6 degree down tilt testing, and the effects of the Bracelet device on intra-vascular volumetric changes.

The research investigations will use a tiered methodology:

I. Ground based investigations at the Johnson Space Center (Evaluation of the cardiovascular effects of the Bracelet device with ultrasound, Ultrasound optimization of Bracelet device application).

II. Simulated Microgravity investigations at the Johnson Space Center (Human factors optimization of stress cardiovascular ultrasound examination, Physiologic effects of simulated microgravity on cardiovascular performance, Effects of the Bracelet device on cardiac function in bed rest subjects).

III. Optimization of just-in-time training methodologies to allow non-expert operators to perform vascular and cardiac ultrasound evaluations at Henry Ford Hospital (Develop rapid hands on methodologies in vascular and cardiac ultrasound, Development and optimization of CD-ROM based training methods in ultrasonography, Compare the accuracy of expert versus just-in-time trained ultrasound operators performing vascular and cardiac ultrasound).

IV. Flight Experiments on the International Space Station (Evaluation of long duration spaceflight on cardiovascular function, Evaluation of the physiologic effects of the Bracelet device on cardiovascular function during long duration spaceflight).

The research investigations will use a tiered methodology: I. Ground based investigations at the Johnson Space Center (Evaluation of the cardiovascular effects of the Bracelet device with ultrasound, Ultrasound optimization of Bracelet device application). II. Simulated Microgravity investigations at the Johnson Space Center (Human factors optimization of stress cardiovascular ultrasound examination, Physiologic effects of simulated microgravity on cardiovascular performance, Effects of the Bracelet device on cardiac function in bed rest subjects) III. Optimization of just-in-time training methodologies to allow non-expert operators to perform vascular and cardiac ultrasound evaluations at Henry Ford Hospital (Develop rapid hands on methodologies in vascular and cardiac ultrasound, Development and optimization of CD-ROM based training methods in ultrasonography, Compare the accuracy of expert versus just-in-time trained ultrasound operators performing vascular and cardiac ultrasound) and IV. Flight Experiments on the International Space Station (Evaluation of long duration spaceflight on cardiovascular function, Evaluation of the physiologic effects of the Bracelet device on cardiovascular function during long duration spaceflight).

The ultrasonic diagnostic investigations in this project will provide a clinically-relevant, increased understanding of cardiovascular physiology as well as significant advances in space medical capabilities to facilitate exploration-class space missions.

The research investigations will use a tiered methodology:

1. Ground-based investigations at NASA Johnson Space Center Evaluation of the cardiovascular effects of the Bracelet device with ultrasound, and ultrasound optimization of the Bracelet device application.

2. Simulated microgravity investigations at NASA Johnson Space Center Human factors optimization of stress cardiovascular ultrasound examination, physiologic effects of simulated microgravity on cardiovascular performance, and effects of the Bracelet device on cardiac function in bed-rest subjects.

3. Optimization of just-in-time training methodologies to allow non-expert operators to perform vascular and cardiac ultrasound evaluations at Henry Ford Hospital Develop rapid, hands-on methodologies in vascular and cardiac ultrasound, development and optimization of CD-ROM-based training methods in ultrasonography, and comparison of the accuracy of expert versus just-in-time-trained ultrasound operators performing vascular and cardiac ultrasound.

4. Flight experiments on the International Space Station Evaluation of long-duration spaceflight on cardiovascular function, and evaluation of the physiologic effects of the Bracelet device on cardiovascular function during long-duration spaceflight.