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NOT YET RECRUITING
NCT06968377
NA

The COVID Dome Trial

Sponsor: IWK Health Centre

View on ClinicalTrials.gov

Summary

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.

Official title: Preliminary Clinical Evaluation of a Novel Airborne Pathogen Containment Device Design: Randomized Open-label Equivalence Trial of Patient Safety and Acceptability During Endotracheal Intubation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-05-15

Completion Date

2026-05-15

Last Updated

2025-05-13

Healthy Volunteers

Yes

Interventions

DEVICE

A novel airborne pathogen containment device.

The dome is placed over the patient's head during the full duration of a surgery (intubation and extubation included) as a method of preventing infection transmission through airborne aerosols throughout a hospital.

Locations (1)

IWK Health Centre

Halifax, Nova Scotia, Canada