Status:
NOT_YET_RECRUITING
The COVID Dome Trial
Lead Sponsor:
IWK Health Centre
Conditions:
Medical Device
Medical Device Performance
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Background and Rationale Pandemic spread of COVID-19 presents an unprecedented challenge for health care systems around the world. A highly infectious respiratory virus with long incubation, asymptoma...
Eligibility Criteria
Inclusion
- 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
- 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
- anxiety disorder (including claustrophobia)
- significant cardiovascular or respiratory disease (including pleural effusion, pulmonary edema, etc.)
- anticipated significant level of post-operative sedation preventing survey participation
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06968377
Start Date
May 15 2025
End Date
May 15 2026
Last Update
May 13 2025
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8