ICU-in-a-Box | SBIR

OUSD (R&E) critical technology area(s): Biotechnology

Objective: Develop (large animal model testing) an autonomous, portable extracorporeal life support platform for prolonged field care that integrates resuscitation, cardiovascular and pulmonary support, and (optionally) electrolyte and medication delivery capabilities.

Description: Severe hemorrhage is the number one cause of preventable combat deaths, followed by airway compromise (Eastridge, 2012), with increased artillery, thermobaric and incendiary munitions use (Remondelli et al. 2023) potentially increasing lung injury prevalence in future conflicts. Following initial trauma, sepsis and multiple-organ failure predominate (Neff et al. 2013). While improvements in point of injury care (tourniquets, hemostatic dressings, etc.) have significantly increased survival in early trauma phases (Chovanes et al, 2012, Cohen et al., 2012), such care is ideally followed by pre-hospital care from trained medical providers during casualty evacuation. However, as reflected by the large-scale combat operations (LSCO) in the Russia-Ukraine war and with Special Operations missions in remote, austere locations, access to definitive medical care may not be available for days, especially in conflict with near-peer adversaries (Keenan and Riesberg, 2017; Remondelli et al. 2023; Epstein et al., 2023).

More people surviving early phases of trauma combined with decreased evacuation opportunities highlights a pressing need for solutions that can provide advanced and sustained resuscitative care for the organ failure sequalae of severe trauma (e.g., hypotension, respiratory failure, acute renal failure). A growing body of technical capabilities and supporting literature suggests that by focusing on the key drivers of mortality, advances in autonomous systems across several areas of critical care could be combined into a single "ICU-in-a-Box". In particular, extracorporeal membrane oxygenation (ECMO) is an alternative to using intubation and mechanical ventilation (under deep sedation) for acute respiratory distress syndrome (Geetha 2024). Because an ECMO system is essentially just a pump and a membrane lung, it offers a strong opportunity to automate oxygenation support—along with other key combat casualty care needs. While current ECMO systems require highly trained operators, largely because of the need to insert large cannulas and the associated thrombotic risks, recent advances can mitigate these limitations. For example, assistive insertion devices (Brattain 2021) and ECMO systems with smaller cannulas (Osmani et al., 2026) reduce the difficulty of insertion; antithrombotic coatings, portable systems (Szentgyorgyi 2025), and alternatives to conventional membrane oxygenators (Conrad 1994) reduce thrombotic risk (at least over shorter periods); and AI/ML advances in general as well as ECMO management computer models (Pladet 2023, Geetha 2024) could support automation. Once venous access is established for automated ECMO, it enables additional interventions. For example, automated algorithms have stabilized mean arterial pressure (MAP) and heart rate for short periods following severe hemorrhage in porcine models (Pinsky 2024); renal replacement therapy (RRT) could mitigate life-threatening electrolyte abnormalities; and extracorporeal blood purification techniques could remove inflammatory mediators, infectious agents, or toxins (Neff 2013).

This SBIR seeks to combine such capabilities into a single, portable, integrated intervention and delivery platform for resuscitation, cardiovascular and lung support. There is additional potential to automate sedation (Daga 2026, Nagata 2023), analgesia (Aissou 2012), and renal replacement therapies (Wieringa 2025). Although these efforts remain relatively immature, their addition to the integrated system could further extend ICU-level, autonomous extracorporeal life support (ECLS) in the austere and operational setting.

Phase I

This topic solicits Direct to Phase II proposals only. Proposers must provide data demonstrating that at the following has been achieved to be considered for award:

A prototype, portable (battery operated) extracorporeal system that can: 1) achieve at least 2 L/min of blood flow and lung support (oxygenation and ventilation); 2) deliver at least 75 mL/min oxygen; 3) exchange at least 40 mL/min carbon dioxide; and 4) at least one of the following:

• An algorithm that maintains oxygenation and ventilation within specified ranges for SpO2 and EtCO2 by adjusting combinations of the following: blood flow, sweep gas, FiO2.
• An algorithm that maintains mean arterial pressure within a specified range using at least one vasopressor and as needed fluid resuscitation (preferably blood, alternatively crystalloid).
• An algorithm that controls blood flow, ultrafiltration, and monitoring of an extracorporeal renal replacement or blood purification system for removing potassium.

Proposers interested in submitting a Direct to Phase II (DP2) proposal must provide documentation to substantiate that the scientific and technical merit and feasibility described above has been met and describes the potential commercial applications. Proposers must describe current O2 transfer and carbon dioxide (CO2) removal rates that can be achieved by the proposed system. The proposed system must directly interface with an oxygen source (e.g., canister, oxygen concentrator) to provide oxygenation and carbon dioxide removal to mitigate acidosis and lactate buildup. Proposals should provide evidence for the maximum duration of support with their proposed system (ideally, > 72 hours).

Documentation should include, reference, or summarize all relevant information including, but not limited to technical reports, test data, prototype designs/models, and performance goals/results.

Phase II

DARPA is interested in novel approaches to develop a fully integrated, portable system that can provide key components of resuscitation during prolonged casualty care (PCC) (e.g. an ‘ICU-in-a-box’). Approaches that only enable a user(s) to interact with/control multiple different systems, i.e. ‘system of systems’ solutions, are not in scope: the goal is to create a single, portable device that is capable of providing all the desired clinical interventions through a single intravenous cannula inserted into a central vein (internal jugular or femoral vein). Given the ultimate goal to be able to deploy the system in conditions where experienced medical care is not available, a primary goal of this SBIR is to develop and integrate algorithms that enable the system to be autonomous.

Assumptions and Expectations:

• Remote monitoring and control are essential to engage remote expert guidance/intervention when the system experiences edge or unanticipated conditions.
• A casualty is cannulated (autonomous cannulation or decision support for cannulation is out-of-scope).
• Local users will have basic medical training (e.g. a field medic) and can set up, initiate, and attach the automated system if guided, but once attached, the system should monitor the casualty itself and provide autonomous interventions to sustain mean arterial pressure, oxygenation, and ventilation. It should address alerts and alarms (system functioning) autonomously or engage a remote expert automatically without local operator intervention.
  • In addition to initiation of the device, local caregivers can be assumed to:
    • Change IV bags after direction
    • Retrieve and attach blood products after direction
    • Retrieve and attach medication after direction
• Sufficient displays to provide status information about the patient and the current/past treatments deployed by the system should be included.
• It is also permissible to include a ‘clinical decision support’ mode that a local operator could respond to in the event a remote expert is unavailable.

Required Capabilities:

• The system must be readily deployable with minimal contact points with the patients.
  • Sensor packages should be minimized and be easily applied to monitor patient state. Proposals that do not require invasive arterial monitoring are preferred. Proposers must specify what sensors are being recommended, how they are intended to be used in austere and operational (military) conditions, and how they are providing the system sufficient physiological information to support the autonomy.
  • The system may have one (1) patient-inserted cannula, preferably no larger than 15Fr (5mm). Proposers must specify which vessels they intend to use (jugular or femoral).
  • The intended circuit design must be provided and include how sufficient blood/fluids and medications will be effectively delivered. Proposals must specifically describe how the proposed solution manages continuous medication delivery (e.g., sedation and analgesia, vasopressors) and bolus fluids (e.g., blood or crystalloid) within the integrated circuit.
  • Proposers must also specify safety parameters that will be implemented in the integrated system.
• As DARPA ultimately envisions a system intended for use in prolonged field care scenarios, proposers must describe the planned size, weight, and power – network connection, cyber security, and cost considerations (SWaP-C3) for the system. It is anticipated that further system development for miniaturization may occur beyond the scope of this SBIR, but the potential to integrate all the provided components in a portable form factor (e.g., a M9 backpack) must be demonstrated.
• The system must be able to provide autonomous support to maintain partial organ function (cardiovascular and lung) and fluid resuscitation in cases of hemorrhage.
  • For lung support, the system will be able to provide ECMO functionality for direct oxygen transfer to the blood. Preferably, full oxygen support (approximately 250ml/min) would be achievable, but in cases where partial oxygen support is proposed (at least 125 ml/min), proposers can assume that the patient is already intubated for respiratory support. Proposals that integrate with mechanical ventilation when present are preferred.
    • In addition to oxygen support, the system should also provide at least 80ml/min CO2 removal (Combes et al., 2024).
  • For cardiovascular support, the system must also be able to provide fluid resuscitation as needed. It must be capable of maintaining perfusion pressure (not just blood pressure) throughout the validation tests (e.g., at least 24 hours) and be able to support significant hemorrhagic trauma models (e.g., model emulating an uncontrolled bleeding scenario of at least 50% of the estimated blood volume over six hours). This support can include blood, artificial blood products, freeze dried blood products, and crystalloid. When fluid is ineffective at maintaining perfusion pressure, the system should titrate vasopressors to maintain specified mean arterial pressure. All interventions must be autonomously controlled by the system.
  • Proposers must describe the planned development and validation of the closed-loop auto-titration algorithms for control of the oxygen saturation level
    • Likewise, they must describe the planned development and validation of the fluid resuscitation algorithms, as well as integration of the oxygenation and resuscitation algorithms into the overall system.
• Proposers must clearly describe the design of all proposed systems and large animal model tests, as well as their relevance to clinically relevant scenarios, such as similarity to human intravascular blood flow, changes in blood oxygenation levels, trauma biomarkers (e.g., lactate, potassium, pH), thrombotic and hemolysis risk checks and histological assessments. Proposers may choose to utilize existing benchtop hardware and approaches for validation of the system functionality, or, alternatively, respondents may propose the development of iterative or new validation approaches as part of their proposal.

Optional capabilities:

• Additional capabilities of interest include RRT and fluid management interventions to treat electrolyte (e.g., hyperkalemia) derangements.
  • o For these, the system would provide basic kidney support via the same circuit that supports oxygenation and fluid resuscitation. This would include providing electrolyte removal and/or fluid resuscitation compensate for acute metabolic derangements. This could include filtering the blood to remove small molecules or other interventions (e.g., absorption) to compensate for cytokines, endotoxins, etc. that can impact sepsis or other inflammatory derangements. More specifically the system should be demonstrated to be able to maintain adequate lactate levels, temperature and pH (approximately within 20% of baseline values) for at least a 24-hour period
• Additional functionality that is not required but is of interest and would boost the strength of a proposed solution, include: automated sedation and/or analgesia and delivery of scheduled medications (e.g., antibiotics) or other as needed medications (e.g., bolus pain control).

The interim and end-phase goals for the base period are as follows for a 24-month base effort followed by a 6-month option. Responders to this topic are strongly encouraged to propose additional interim assessments to further demonstrate progress toward the goals specified below.

Month 1: Report on initial circuit architectures, sensors, algorithms and animal models and development strategy and timeline

Month 3:

• Interim report on integration of extracorporeal support subsystems (i.e. sensor package(s), lung and cardiovascular systems, plus any planned optional capabilities, e.g., electrolyte support)
• Interim report on development of automation algorithms
• Report on development of initial ex vivo, computational simulation, etc. testing environments

Month 6: Report on development strategy for large animal model(s): can utilize animal models for testing each subsystem (6 hrs for hemorrhage models, 12 hrs for other interventions), including regulatory (IACUC, ACURO) timelines

Month 9:

• Interim report describing performance (ex vivo, sims) of prototype system, automation algorithms and refinements to ex vivo testing environments
• Report on regulatory status/approval of large animal model(s)

Month 12:

• Interim report describing performance (ex vivo, sims) of prototype system, automation algorithms
• Interim report describing development status of large animal model(s)

Month 15:

• Interim report describing performance (in vivo) of prototype system in separate animal models
• Report on clinical regulatory approval strategy (e.g., FDA engagements).

Month 18:

• Interim report describing performance (in vivo) of prototype system in separate animal models
• Report on strategy for developing a large animal model that combines assessments for all subsystems (e.g., polytrauma model) in order to validate system performance during simultaneous deployment of all automation algorithms (maintaining hemostasis for 24-hours) including regulatory (IACUC, ACURO) timelines

Month 21: Report on regulatory status/approval of large animal polytrauma model

Month 24:

• Final report summarizing approach; prototype architecture and algorithms; separate large animal model testing results (including thrombotic, hemolysis and histological assessments, as well as efficacy of algorithms in maintaining goal biomarkers, e.g., SpO2, EtCO2, MAP, etc.), bill of materials for the prototype as well as SWaP-C3 feasibility for future fully portable designs, and use of consumables (e.g. O2, fluids, vasopressors, etc.).
• Report on regulatory development strategy and any FDA engagements.
• Report on development of polytrauma model and recommendations for its use in a preclinical study for in vivo assessments of the prototype device including updated recommendations for a regulatory strategy (e.g., FDA engagements).

Option Period 1: Proposals that respond to Option Period 1 may also include a sequential 6-month option period for a pre-clinical pilot study to demonstrate and validate the functionality of their integrated breadboard system in a large animal model.

Month 25:

• Report on regulatory approval status for 24-hour large animal model that combines all interventions (e.g., polytrauma model)
• Report on experimental testing strategy and timeline

Month 28:

• Interim report describing integration of all prototype subsystems and automation algorithms
• Interim report describing performance (in vivo) of prototype system in 24-hour large animal model polytrauma model

Month 30: Final report documenting final prototype architecture and algorithms; methods; all results; and proposed strategy for a portable form factor compatible with far forward deployment in austere conditions (i.e., SWaP-C3 assessment), and final regulatory status and FDA engagements.

Phase III dual use applications

This SBIR has potential applicability across DoW and commercial entities. Commercial applications include integration of this autonomous extracorporeal support platform into civilian critical care transport (rotor-wing, fixed-wing, and ground ambulance services), rural and community hospital as a bridge-to-transfer where on-site critical care expertise is unavailable, and in mass-casualty or disaster-response settings where trained critical care staff are scarce or evacuation times are long.

Military and DoW applications include incorporation into Prolonged Casualty Care and equipment sets for Special Operations Forces, forward surgical teams, and casualty evacuation platforms across air, ground, and maritime domains, including uncrewed evacuation systems, enabling extended en-route and prolonged field care for casualties with severe injuries (battle or disease non-battle) in contested or resource-limited operational environments. In these settings, an autonomous, portable extracorporeal life support system will provide options to sustain the force that do not currently exist.

References

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Keywords

Autonomous Systems, Life Support Systems; Resuscitation; Trauma; Shock; Casualties; ARDS; multiple organ failure

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