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

80 Participants Needed

Trial Summary

What is the purpose of this 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 of germs through the air in hospitals. The researchers are interested in the following outcomes: * How the device affects the patients' experience of surgery. * The impact of the device on how long it takes to place a breathing tube, blood pressure, heart rate and oxygen levels of the patient. Researchers will compare the outcomes across patients using the device and patients not using the device. This will be done by randomly (by chance) assigning participants undergoing surgery to group 1 (using the bubble-like dome device) or group 2 (not using the device). Participants will: * Tell the researchers or your anesthesia doctor about any problems that you experience that you think might be related to participating in the study. * Fill out a 10-minute survey regarding your experience with the dome after surgery. * If you did not try the dome before going to sleep, you will be able to watch a video of the dome in use and answer questions based on the video * Be video recorded with your time with the dome.

Eligibility Criteria

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

I am planning to have elective surgery.

Endotracheal intubation is indicated as per attending anesthesiologist

I am over 18 years old.

Exclusion Criteria

My BMI is over 40.

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

Predictors of difficult airway management as per attending anesthesiologist

Timeline

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

Treatment Details

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.

Participant Groups

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+