PPE and Air Hygiene for Flu Prevention

(EMIT-2 Trial)

No longer recruiting at 1 trial location

Overseen By Sarah Litts, MS, BSN, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Asthma medications, Immunosuppressants

Disqualifiers: Respiratory, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how personal protective equipment (PPE) can prevent the airborne spread of the flu. Participants are divided into groups: one uses PPE to determine its effectiveness in stopping flu transmission, while the other does not. The trial seeks individuals who have recently had the flu or have not had it but are willing to use PPE for the study. Ideal candidates do not smoke or have complex health issues requiring ongoing medical treatment. As an unphased trial, this study allows participants to contribute to important research on flu prevention.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are on medications that suppress the immune system or treat significant medical conditions like respiratory or cardiovascular diseases, you may not be eligible to participate.

What prior data suggests that personal protective equipment (PPE) is safe for flu prevention?

Research has shown that personal protective equipment (PPE), such as masks, gloves, and face shields, is generally safe to use. Designed to protect against germs, these items are commonly used in healthcare settings. Studies have found that PPE, when used correctly, can reduce the risk of infection without harming the user.

No major reports of problems from wearing PPE have emerged. However, proper use is crucial for effectiveness. For instance, face masks should fit snugly, and hands should be clean when putting on gloves. This ensures that PPE remains a safe and effective method for preventing flu and other infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personal protective equipment (PPE) might prevent the spread of influenza. Unlike typical flu prevention methods, such as vaccines and antiviral medications, this approach focuses on using PPE to block airborne transmission. This trial could reveal how effective PPE is as a preventive measure, potentially offering a simple and accessible way to reduce flu transmission, especially in settings where vaccines aren't available or effective.

What evidence suggests that personal protective equipment is effective for flu prevention?

This trial will compare the use of personal protective equipment (PPE) with no intervention for flu prevention. Studies have shown that face masks can greatly protect healthcare workers from infections. However, research on their effectiveness for the general public remains less clear. Some reviews have found no strong evidence that face masks reduce flu infections among everyday people. Gloves, although used in some situations, have not shown a clear effect on stopping respiratory viruses like the flu. Overall, PPE might help but does not guarantee flu prevention. It is best used as part of a broader prevention strategy. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-49 who have recently contracted the flu. Participants must understand the study, stay in a research unit for about 5 days, and attend follow-ups. Pregnant or breastfeeding women, smokers, those with severe allergies to medicines, immunosuppressed individuals or those on certain medications cannot join.

Inclusion Criteria

I've had a fever over 100.2°F and a cough or sore throat in the last 3 days without another known cause.

I agree to the study's terms and can stay in quarantine for about 5 days.

You have been diagnosed with the flu in the last 72 hours.

Exclusion Criteria

I am immunosuppressed or take medication that affects my immune system.

Known allergy or intolerance to treatments for influenza and other respiratory infections.

Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are exposed to controlled human influenza virus infection and interventions to reduce airborne transmission are implemented

2 weeks

Follow-up

Participants are monitored for serological, symptomatic, and viral confirmation of influenza infection

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No Intervention
• Personal Protective Equipment (PPE)

Trial Overview

The EMIT-2 trial is testing how well Personal Protective Equipment (PPE) works under different air hygiene conditions to prevent airborne transmission of influenza. People will be randomly assigned to either use PPE or not under low and high air cleanliness settings.

How Is the Trial Designed?

Group I: Intervention Recipients Experimental Treatment 2 Interventions

Intervention recipients are participants who do not have influenza and will use personal protective equipment.

Group II: Donors Experimental Treatment 2 Interventions

Donors are persons naturally infected with influenza.

Group III: Control Recipients Active Control 1 Intervention

Control recipients are participants who do not have influenza and will not be using personal protective equipment.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The study found that the highest rates of non-percutaneous body fluid exposure (NP BFE) occurred in the emergency department (51.3%) and intensive care unit (30.8%), highlighting a significant risk for healthcare workers in these settings.

Despite nurses' awareness of the importance of using personal protective equipment (PPE) for preventing NP BFE, compliance was very low, with only 0% using face shields or masks, indicating a need for improved safety practices and training in high-risk areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the selection and use of "other" personal protective equipment to prevent mucous membrane exposure in nurses: A cross-sectional study. Zimmerman, PA., Byrne, JH., Gillespie, BM., et al.[2023]

The implementation of a surgical safety checklist in an orthopedic department led to a significant reduction in postoperative fever, decreasing from 10.6% to 5.3% among patients, based on a study of 760 patients over a year.

The checklist also improved the administration of prophylactic antibiotics, with a notable increase in patients receiving appropriate preoperative treatment, which may have contributed to the reduction in fever rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Surgical Safety checklist implementation on the occurrence of postoperative complications in orthopedic patients. Boaz, M., Bermant, A., Ezri, T., et al.[2014]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

In a study of 3669 hospitalized children in Canada, the overall rate of adverse events was found to be 9.2%, with a higher frequency in academic pediatric centers compared to community hospitals (adjusted odds ratio of 2.98).

While the incidence of preventable adverse events was similar across hospital types, nonpreventable adverse events were more common in academic centers, highlighting a need for improved safety measures, especially related to surgical procedures and diagnostic errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study. Matlow, AG., Baker, GR., Flintoft, V., et al.[2022]

Using filtering face-piece respirators (FFR) and half-face masks during CPR significantly decreased the quality of chest compressions, leading to fewer compressions per minute and shallower compressions compared to surgical masks and no masks.

Participants reported increased fatigue when using FFR and half-face masks, indicating that these types of PPE may hinder the effectiveness of CPR efforts by exhausting rescuers more quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Different Personal Protective Equipment Masks on Health Care Workers' Cardiopulmonary Resuscitation Performance During the Covid-19 Pandemic. Serin, S., Caglar, B.[2021]

Most adverse incidents related to health technology can be prevented with proper understanding and action.

The paper identifies 10 specific sources of potential danger in healthcare technology for 2011, providing recommendations to enhance patient and staff safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 technology hazards for 2011. A guide for prioritizing your patient safety initiatives. [2011]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

In a study conducted in Liberia, 83% of healthcare facilities reported limited access to personal protective equipment (PPE), highlighting a significant challenge for clinicians in low-income countries.

Clinicians employed various coping strategies to manage PPE shortages, such as rationing, self-purchasing, and substituting PPE, which may negatively impact both healthcare workers and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How clinicians manage routinely low supplies of personal protective equipment. Ridge, LJ., Stimpfel, AW., Dickson, VV., et al.[2022]

Wearing personal protective equipment (PPE) did not significantly affect the time it took to perform tracheal intubation across various techniques, indicating that PPE can be used without delaying the procedure.

Participants reported discomfort, particularly with face shields, which were found to be uncomfortably hot, suggesting that while PPE is effective, its comfort and usability in real clinical situations need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal protection equipment for biological hazards: does it affect tracheal intubation performance? Greenland, KB., Tsui, D., Goodyear, P., et al.[2020]

A survey of 292 healthcare workers in ICUs revealed that only 63% correctly identified adequate personal protective equipment (PPE) for preventing influenza, indicating significant knowledge gaps.

Despite 62% reporting high adherence to PPE use, the study suggests that actual adherence may be lower, highlighting a substantial risk for healthcare-associated influenza transmission in high-risk settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of personal protective equipment for control of influenza among critical care clinicians: A survey study. Daugherty, EL., Perl, TM., Needham, DM., et al.[2009]

The implementation of an influenza control bundle in the medical ICU significantly reduced influenza infections among healthcare workers from 3.4 to 0 cases per 1,000 HCW-days, demonstrating its effectiveness in preventing transmission.

The intervention also led to a substantial increase in vaccination rates among MICU healthcare workers from 71% to 100%, highlighting the importance of education and promotion in improving vaccination coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of seasonal influenza transmission among healthcare workers in an intensive care unit: a 4-year intervention study in Thailand. Apisarnthanarak, A., Uyeki, TM., Puthavathana, P., et al.[2015]

A review of 14 randomized controlled trials found that nonpharmaceutical measures like hand hygiene and face masks did not significantly reduce the transmission of laboratory-confirmed influenza in nonhealthcare settings.

There is a critical need for further research to better understand how influenza spreads between people, as current evidence on the effectiveness of hygiene and environmental cleaning measures is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings-Personal Protective and Environmental Measures. Xiao, J., Shiu, EYC., Gao, H., et al.[2021]

Hospitals should prepare at least 4 sets of PPE per day for high-risk healthcare workers, and 2 sets for medium- and low-risk groups, to effectively manage during an influenza pandemic.

The proposed PPE calculation system helps hospitals determine the necessary stockpile, recommending supplies to last for at least 8 weeks during a pandemic, which is crucial for ensuring safety and preparedness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stockpile of personal protective equipment in hospital settings: preparedness for influenza pandemics. Hashikura, M., Kizu, J.[2021]

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