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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIWK Health Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA class 1 and 2

Elective surgery

Adults >18 years of age

Ability to give informed consent

Disqualifiers

BMI >40

pregnancy

"full stomach" or increased intraabdominal pressure (as per attending anesthesiologist)

predictors of difficult airway management as per attending anesthesiologist

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DomeExperimental treatment 1 intervention
Group B: No domeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Duration of time needed to place an airway (seconds)

Difference in means of airway times with and without the device present.

Time frame
Day of surgery (intubation)

Secondary outcomes

1

First pass intubation success rate (%)

Proportion of patients in each arm who required more than one attempt at endotracheal tube placement.

Time frame
Day of Surgery - intubation (indicated by the moment the laryngoscope tip first touches the patient's mouth)
2

Incidence of SaO2 <90%

Count of patients in each arm who had SaO2 \<90% for any length of time within after induction of anesthesia and within 5 minutes of airway placement.

Time frame
During time spent in surgical recovery room

Other outcomes

1

Mean nadir ETO2 (%)

End-tidal oxygen (ETO2) is the concentration of oxygen in exhaled air the end of exhalation.

Time frame
within 1 minute of delivery of first breath post-intubation
2

Mean nadir ETCO2 (%)

End-tidal Carbon Dioxide (ETO2) is the concentration of CO2 in exhaled air the end of exhalation.

Time frame
Within 1 minute of first breath through endotracheal tube.
3

Device satisfaction survey score

Mean anesthesiologist VAS "ease of airway management score"

Time frame
Day of surgery
4

Mean patient visual analogue scale (VAS) satisfaction score with the experience of "going to sleep" - Survey A

The survey will seek input regarding patients' recollection of anxiety, comfort and overall acceptability prior to anesthesia induction and on emergence. Both cases and controls will be asked to answer the same questions. The aim of this part of the survey is to assess to what extent the presence of the device impacts patients' anesthesia experience. Part A questions were developed using a VAS for anxiety that has been validated in patients recovering from anesthesia. In addition, we will ask them to what extent they felt the team attended to their comfort and the overall satisfaction with their experience of the time period prior to anesthetic induction.

Time frame
Administered within 24-hours of surgery, after sufficient cognitive recovery.

Sponsors and contacts

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