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

RecruitingNAAges 18 Years - anyAllIWK Health Centre
NCT06968377 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. *

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📋 Eligibility rules (as published)
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
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What it tests

  • A novel airborne pathogen containment device.
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Where

1 site
IWK Health Centre
Halifax, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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