The COVID Dome Trial
Trial statusNot yet recruiting
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 volunteersQualifiers
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.
DeviceThe 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 groupsGroup 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.
Difference in means of airway times with and without the device present.
Time frame
Day of surgery (intubation)Secondary outcomes
1
Mean delta ETCO2
End-tidal carbon dioxide (ETCO2) is the level of carbon dioxide that is released at the end of an exhaled breath.
Time frame
For 5 min pre- and post- intubation2
First pass intubation success rate (%)
Intubation - insertion of an endotracheal tube in a patient
Time frame
Day of Surgery - intubation3
Patient Body Mass Index
Time frame
Day of Surgery4
Blood Pressure
Systolic and diastolic blood pressure
Time frame
Every 1 minute during surgery (at least 2 measures taken prior to device deployment and 2 prior to induction)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: