Airborne Pathogen Containment Device for Aerosol Generating Procedures

Overseen By Ana Sjaus, MSc, MD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: IWK Health Centre

Disqualifiers: BMI >40, Pregnancy, Anxiety, others

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

Compensation: Varies

Number of Visits: 2

Duration: Day of surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new clear plastic dome that fits over patients' heads during surgery to prevent the spread of germs in the air. Researchers aim to assess how the dome affects patients' surgery experience and specific health measures, such as blood pressure and oxygen levels. Participants will be randomly assigned to either use the dome or not during their surgery. Individuals scheduled for elective surgeries, such as abdominal or limb procedures, and who can have a breathing tube placed, might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical practices that could enhance patient safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this device is safe for use during surgery?

Research shows that the bubble-like dome device used in surgeries helps limit the spread of airborne germs. Studies have found that similar devices can reduce exposure to airborne particles by 90%, suggesting the device could effectively prevent infections that spread through the air.

Regarding safety, the device covers the patient during surgery without obstructing medical care. Made of clear plastic, it allows doctors and nurses to see and treat the patient. No studies have reported problems directly caused by these devices. However, researchers continue to investigate patient comfort and ease during surgery.

This trial is in the "Not Applicable" phase, focusing on the dome's functionality rather than its safety. The safety of the device remains under review, but past studies on similar devices suggest they are generally safe. Participants will report any issues experienced during the trial, contributing to a better understanding of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to keep both patients and healthcare workers safer during procedures that create aerosols, like certain surgeries. Unlike standard surgical protocols where there might be minimal physical barriers to contain airborne pathogens, this trial introduces a large, clear dome that acts as a physical barrier. This innovative device allows doctors and nurses to perform their duties without directly exposing themselves to potentially infectious aerosols. The hope is that this dome can significantly reduce the risk of airborne transmission, offering a new layer of protection in medical settings.

What evidence suggests that this airborne pathogen containment device is effective for preventing the spread of germs during surgery?

Research has shown that devices like the bubble dome, which participants in this trial may receive, can greatly reduce airborne particles in medical settings. One study found that these devices lowered aerosolized particles by 87–94%. Another study confirmed that well-designed devices reduced tiny particles in the air by over 90%. This evidence suggests that the dome might help prevent germs from spreading during surgeries. Although this specific dome is new, these results indicate it could effectively keep the air cleaner around patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients undergoing surgery who are willing to have a bubble-like dome placed over their heads to prevent airborne germ spread. Participants must be comfortable with being video recorded and able to provide feedback through a survey or interview.

Inclusion Criteria

Endotracheal intubation is indicated as per attending anesthesiologist

I am planning to have elective surgery.

I am over 18 years old.

Exclusion Criteria

Pregnancy

Presence of a 'full stomach' or increased intraabdominal pressure as per attending anesthesiologist

Predictors of difficult airway management as per attending anesthesiologist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with or without the dome device, with intubation and monitoring of physiological parameters

Day of surgery

1 visit (in-person)

Follow-up

Participants complete surveys regarding their experience and are monitored for safety and effectiveness after surgery

Within 24 hours post-surgery

1 visit (in-person or virtual)

Data Analysis and Review

Data from the trial is analyzed to determine the success of the device and identify any necessary redesigns

What Are the Treatments Tested in This Trial?

Interventions

• A novel airborne pathogen containment device

Trial Overview The study tests a clear plastic dome designed to contain pathogens during surgeries. It measures the device's effect on patient experience, surgical procedure times, and vital signs by comparing two groups: one using the dome and one without it.

How Is the Trial Designed?

Group I: Dome Experimental Treatment 1 Intervention

The device is a large, bubble-like dome made of clear plastic through which doctor and nurse can care for the patient during surgery.

Group II: No dome Active Control 1 Intervention

Standard care during surgery.

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06968377

Study Details | NCT06968377 | The COVID Dome Trial The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8457543/

Aerosol Production with Surgical Instrumentation In our study, simultaneously applied suction results in a significant reduction in aerosols of all sizes generated from the surgical field. In our data, for ...

3. withpower.com withpower.com/trial/phase-medical-devices-4-2025-5816c

Airborne Pathogen Containment Device for Aerosol ... The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735675722007008

Aerosol containment device design considerations and ... ACDs should reduce exposure among HCP with the device compared with the absence of the device, and provide ≥90% reduction in respirable aerosols.

5. nature.com nature.com/articles/s41598-025-03705-1

Development and validation of the airway surgery ... The ASE demonstrated an 87–94% reduction in aerosolized particle concentration compared to ambient room levels. Bench testing validated the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9650508/

Aerosol containment device design considerations and ... ACDs should reduce exposure among HCP with the device compared with the absence of the device, and provide ≥90% reduction in respirable aerosols.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7494260/

Are aerosol-generating procedures safer in an airborne ... ' Some readers may interpret the ASA recommendation to imply increased safety when performing aerosol-generating procedures in an airborne ...

8. vumc.org vumc.org/infection-prevention/sites/default/files/public_files/COVID%2019%20AGP%20FAQs%20%2811%29.pdf

Aerosol Generating Procedures (AGP) FAQs for Clinicians These AGPs require personal protective equipment (PPE) to protect the health care workers. While many aerosols are large enough and are effectively filtered by ...

9. cdc.gov cdc.gov/infection-control/hcp/environmental-control/air.html

C. Air | Infection Control Containment of the aerosol at the source is the first level of engineering control, but personal protective equipment (e.g., masks ...