HAIQU (Hospital AIr QUality) (HAIQU)
HAIQU (Hospital AIr QUality): Breathing Life Into Patient Care
研究概览
详细说明
Executive Summary. The Hospital AIr QUality (HAIQU) team will develop a biosensor and risk assessment software to detect pathogens in indoor air, to be integrated with building management system (BMS), focusing on improving indoor air quality in hospitals to reduce disease transmission and enhance patient outcomes. The HAIQU biosensor will combine high-flow-rate aerosol collection highly sensitive and specific CRISPR detection, and digital droplet microfluidics to continuously detect multiple viral, bacterial, and fungal pathogens from indoor air. The HAIQU risk assessment software will combine multi-scale modeling into a 'digital twin', or virtual representation of an indoor space to model pathogen distribution and exposure risk to occupants. The HAIQU tools will be applied in clinical studies within the emergency departments (EDs) of Mayo Clinic campuses in MN, WI, AZ, and FL. Integrating with building control systems, the HAIQU biosensor and software will inform strategies to mitigate bioaerosol risks, enhance productivity, save energy and costs, and protect the health of staff and patients. By ensuring clean and safe indoor air, these tools will contribute to smarter, more resilient buildings that improve cognitive performance, wellness, and overall human health.
Goals and Impact. Although people spend the majority of our time indoors, indoor air quality (IAQ) is often overlooked, with more attention given to outdoor air quality. However, clean indoor air is essential for health and well-being. Monitoring of indoor air currently lags behind other 'big data' surveillance technologies, such as wearable health monitors and disease tracking. HAIQU aims to bridge this gap by developing rapid, real-time biosensing and risk assessment tools for healthier and safer hospital buildings. Current biosensing methods are slow, non-autonomous, and limited to detecting only a few pathogens at a time. Typically, aerosol samples are collected onto a filter over two to eight hours, then manually processed for detection, often using nucleic acid amplification. For example, researchers at Mayo performed clinical trials using the Thermo Scientific AerosolSense paired with the Renvo Rapid PCR Test to detect influenza A/B, SARS-CoV-2, and RSV. Though advanced microfluidic nucleic acid amplification methods exist that are more conductive to multiplexing, combining these methods with continuous or semi-continuous aerosol collection for rapid, autonomous detection is still lacking. To detect bioaerosols which are present at very low concentrations (<1 per L), high flow rate sampling must be paired with highly sensitive, multiplexed detection methods. Here, the investigators propose the HAIQU biosensor, a portable device that enables rapid, autonomous, and near real-time bioaerosol detection. It combines high flow rate virtual impactors and condensers for aerosol capture with drop-based microfluidics, CRISPR-Cas-based detection, and multiplexed barcoding. The healthcare environment provides an ideal use case for the proposed technologies. In EDs, patients often present with undiagnosed infectious diseases that can lead to significant exposures and outbreaks among staff, patients, and visitors, sometimes only recognized after diagnosis. Detection of airborne pathogens can prevent and reduce hospital-acquired infections, which are a leading cause of illness and lost worktime.
TECHNICAL AREA 1: The final HAIQU biosensor will be capable of detecting multiple pathogens (25 real-world, viral + bacterial + fungi; 100 lab-based) with >95% sensitivity and >99% specificity, once every 45 minutes.
TECHNICAL AREA 2: HAIQU risk assessment software will include a multiscale modeling framework to predict and assess infectious disease risk in indoor environments. The multi-scale modeling framework incorporates scales from individual events to room-level and system-level information, to yield outputs and predictions of bioaerosol dispersion, infection risk, number infected, intervention recommendations, and energy calculations.
TECHNICAL AREA 3: Multi-site field trials using the HAIQU biosensor and software in Mayo Clinic's emergency departments will be performed targeting a 25% decrease in facility-related incidence of each targeted respiratory illness relative to baseline data. Biosensor data will be combined with air quality sensing data and multi-system building controls and intervention.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:HAIQU Research Staff
- 电话号码:507-422-3077
- 邮箱:BreatheResearch@mayo.edu
学习地点
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Arizona
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Phoenix、Arizona、美国、85054
- Mayo Clinic Arizona
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic Florida
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Target Group:
- Mayo Clinic Staff working in ED with a minimum of .7 FTE in Midwest (MN and WI), Phoenix (AZ), or Jacksonville (FL) and patient contact.
Reference Group:
- Mayo Clinic Staff working in primary care with a minimum of .7 FTE. in Rochester (MN), Phoenix (AZ), or Jacksonville (FL) and patient contact
Exclusion Criteria:
- Any participant who does not meet either of the inclusion criteria.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Emergency Department Employees
Emergency Department employees will act as the target group with the Emergency Department building implementing the HAIQU air quality sensor.
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Participants will self-report when they are experiencing respiratory symptoms and will be asked for a self-swab to be used for data analysis.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants to experience acute respiratory infection (ARI) symptoms
大体时间:3 years
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Symptoms include: at least 2 upper respiratory symptoms for at least 24 hours; OR at least 2 symptoms that include an upper/lower respiratory symptom and a systemic symptom (fever, fatigue, body aches, headache, decreased appetite) for at least 24 hours
|
3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of confirmed cases of acute respiratory infections
大体时间:3 years
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Number of cases confirmed by at least one viral panel-positive swab detected by RT-PCR
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3 years
|
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Number of confirmed cases of lower respiratory tract disease
大体时间:3 years
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Number of cases of lower respiratory tract disease confirmed by at least one viral panel-positive swab detected by RT-PCR
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3 years
|
合作者和调查者
赞助
调查人员
- 首席研究员:Connie Chang, Ph.D.、Mayo Clinic
- 首席研究员:Chung Wi, M.D.、Mayo Clinic
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 24-013166
- ARPA-H-SOL-24-107 (其他赠款/资助编号:ARPA-H BREATHE)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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