Recruiting

Bubble Dome

Sponsor:

IWK Health Centre

Code:

NCT06968377

Conditions

Medical Device

Medical Device Performance

Aerosol Generating Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

A novel airborne pathogen containment device.

Study Details

Brief 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.

Conditions

Medical Device

Medical Device Performance

Aerosol Generating Procedure

Study ID

NCT06968377

Start date

Jan 7, 2026

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Dome

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

no intervention: No dome

Standard care during surgery.

Interventions

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.

Primary outcome measure

  • Duration of time needed to place an airway (seconds) [ Time Frame: Day of surgery (intubation) ]

Central Contacts and Locations

Central contacts

Ana Sjaus, MSc, MD, FRCPC

1-902-470-6627anesthesiaresearch@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Ana Sjaus, MSc, MD, FRCPC

1-902-470-6627

More Information

Sponsor

IWK Health Centre

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2026-09-16.