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Clinical Evaluation of an Airborne Pathogen Containment Device: Randomized Open-label Equivalence Trial During Endotracheal Intubation

Sponsor: IWK Health Centre • ClinicalTrials.gov ID: NCT06968377

Registry updated: 2026-09-16

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Description

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.

Interventions

A novel airborne pathogen containment device. (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.

Eligibility criteria

Inclusion Criteria: * ASA class 1 and 2 * Elective surgery * Adults \>18 years of age * Ability to give informed consent * Surgery in supine or lithotomy position * Surgical site: abdominal, pelvic, lower limb or distal upper limb * Endotracheal intubation is indicated as per attending anesthesiologist Exclusion Criteria: * BMI \>40 * pregnancy * "full stomach" or increased intraabdominal pressure (as per attending anesthesiologist) * predictors of difficult airway management as per attending anesthesiologist * airway management plan (as per attending anesthesiologist) that is incompatible with study protocol * initial ventilatory settings that are incompatible with planned care as per study protocol * Claustrophobia * significant cardiovascular or respiratory disease (including pleural effusion, pulmonary edema, etc.) * anticipated significant level of post-operative sedation preventing survey participation

Conditions

Medical Device Medical Device Performance Aerosol Generating Procedure

Locations

IWK Health Centre — Halifax, Nova Scotia, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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