IntubationNCT04865081
Clinical Evaluation of an Aerosol Protective Intubation Device on Videolaryngoscopic Intubation Difficulty
A study testing VACCIN box in people with Intubation, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- VACCIN box
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 19 Apr 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective surgery requiring general anesthesia with tracheal intubation
- ASA status I, II or III
- Good understanding of English or French
Who cannot join
- Known difficult airway
- Anticipated difficult airway (Mallampati ≥ 3, oral opening < 2.5 cm, thyromental distance < 6 cm, limited cervical mobility, significant abnormality of the upper respiratory tract, history of major surgery on airway or cervical area)
- COVID-19 positive or unknown status
- Rapid sequence contraindication
- Presence of antibiotic-resistant bacteria requiring a form of additional protective equipment
- Claustrophobia
Show all 13Show fewer
- Chronic anxiety
- BMI ≥ 35
- Allergy or intolerance to any of the study drugs
- Emergent surgery
- Pregnancy
- Preoperative hemodynamic disturbance
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve Rosemont Hospital
Montreal, Quebec, H1T 2M4
Issam Tanoubi, MD, 514 252 3400 ext. 3426, i.tanoubi@umontreal.ca
About this study
Official title: First Randomised Controlled Clinical Evaluation of the Impact of Anti-Aerosol VACCIN Box on the Videolaryngoscopic Intubation Procedure
The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. This study will compare the safety and the ease of use of the VACCIN box to a standard intubation in healthy participants undergoing elective surgery. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box.
Read the detailed description
Novel ways to protect healthcare workers were developed around the world in the setting of the COVID-19 (SARS-CoV-2) pandemic. Shortage of personal protective equipment (PPE) and concern of potential viral transmission during aerosol generating procedures such as endotracheal intubation fueled the emergence of intubation boxes. However, a lack of details about their safety and efficiency remains.
This study will evaluate safety and ease of use of the VACCIN box in participants undergoing elective surgery requiring endotracheal intubation. The study design is a prospective randomized single center clinical trial comparing intubation with and without its use. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box. Eligible participants will be randomized in a 1:1 ratio after informed consent.
Participants in both groups will be intubated in the same circumstances. The procedure include a midazolam anxiolysis, a rapid sequence induction without cricoid pressure of predefined dosing of remifentanil, propofol and rocuronium and monitoring of an adequate muscles paralysis and dept of anesthesia.
Anesthesiologists will intubate in both groups using specific material: McGRATH videolaryngoscope with X-Blade, 8 mm endotracheal tube (ETT) for men or 7 mm for women and the Glidescope videolaryngoscope stylet inside the ETT.
The experimental group will differ from the control group by application of the VACCIN box over the participant's head through which the anesthesiologist will intubate. Proper installation and removal of the VACCIN box will also be evaluated.
Intubations will only be done by anesthesiologists to assure patient safety. Each anesthesiologist will be assigned a practice session using the VACCIN box on an intubation mannequin prior to the study.
Time measurements throughout the procedure will be taken to obtain the outcomes measures. Vital signs, TOF, NOL index and BISpectral index monitoring are part of the protocol in order to assure an adequate anesthesia induction prior and after intubation.
A total of 60 participants will be enrolled in the study (30 in each group). Sample size calculation was based on local intubation mean time with COVID-19 pandemic protocols of 45 seconds with a 15 seconds standard deviation (SD). 26 participants per group are needed considering that an intubation time that is 30% or more over the current mean would imply that the VACCIN Box slowed down the intubation with an assumed SD of 15 seconds, a significance level of 5% and power of 90%. Sample size per group was rounded up to 30 in order to overcome possible exclusion or loss.
The primary outcome, the intubation time in seconds, will be tested for normal distribution with a D'Agostino-Pearson omnibus normality test and analyzed using a Two-tailed Student t test for unpaired groups. The intubation time will be presented as mean and standard deviation [SD].
For the secondary outcomes, the χ2 test will be used for the comparisons of the success rate of intubation at first laryngoscopy. The Mann-Whitney U test will be used to compare the ease of intubation.
- Conditions
- Intubation
- Being tested
- VACCIN box
- Keywords
- videolaryngoscopy, intubation box, aerosol box, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACCIN boxDevice
The VACCIN box is a translucid box that can be placed over the patient's head. It has entry holes on the front and the side of the box in which nitrile gloves can be attached. The anesthesiologist can intubate with arms and hands inside the box. Its also has the capacity to create a negative pressure environment inside the box by connecting an air suction cable from the box to the OR medical aspiration line.
| Study group | Role | What they receive |
|---|---|---|
| VACCIN box group | Experimental | The anesthesiologist will intubate the participants in the VACCIN box group while using the VACCIN box that will be placed over the participants' head. Receives: Device: VACCIN box |
| Control group | No intervention | Enrolled participants in the control group will be intubated without the use of the VACCIN intubation box (standard anesthesia). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Seconds
Measured: Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor
Secondary outcomes (10)
Success rate of intubation at first laryngoscopy
Percentage
Measured: Immediately after the intubation
Ease of tracheal intubation
Numeric scale of 0 to 10
Measured: Immediately after the intubation
VACCIN box installation time
Seconds
Measured: The VACCIN box installation time will correspond to the time interval in the experimental group between the start of the VACCIN box placement over the participant's head to the removal of the preoxygenation mask before intubation.
VACCIN box removal time
Seconds
Measured: The VACCIN box removal time will correspond to the time interval in the experimental group between the initial detection of end-tidal CO2 on the anesthesia monitor to the complete removal of the VACCIN box.
Breach of air tightness
Percentage
Measured: Immediately after the intubation
Qualitative reviews on intubation with the VACCIN box
Qualitative
Measured: Immediately after the intubation
Non-invasive blood pressure variations around tracheal intubation
mmHg
Measured: before, during and for 5 minutes after tracheal intubation
Heart rate variations around tracheal intubation
bpm
Measured: before, during and for 5 minutes after tracheal intubation
NOL variation (NOL is an index without unit) around tracheal intubation
Varies from 0 to 100, no unit
Measured: before, during and for 5 minutes after tracheal intubation
Bispectral index (BIS) variation (BIS is an index without unit) around tracheal intubation
Varies from 0 to 100, no unit
Measured: before, during and for 5 minutes after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start19 Apr 2021
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam TANOUBI, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865081
- Sponsor's protocol ID
- 20212465
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Randomised Controlled Clinical Evaluation of the Impact of Anti-Aerosol VACCIN Box on the Videolaryngoscopic Intubation Procedure
- ClinicalTrials.gov ID
- NCT04865081
- Acronym / sponsor ID
- 20212465
- Conditions
- Intubation
- Keywords
- videolaryngoscopy, intubation box, aerosol box, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. This study will compare the safety and the ease of use of the VACCIN box to a standard intubation in healthy participants undergoing elective surgery. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box.
Detailed description
Novel ways to protect healthcare workers were developed around the world in the setting of the COVID-19 (SARS-CoV-2) pandemic. Shortage of personal protective equipment (PPE) and concern of potential viral transmission during aerosol generating procedures such as endotracheal intubation fueled the emergence of intubation boxes. However, a lack of details about their safety and efficiency remains.
This study will evaluate safety and ease of use of the VACCIN box in participants undergoing elective surgery requiring endotracheal intubation. The study design is a prospective randomized single center clinical trial comparing intubation with and without its use. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box. Eligible participants will be randomized in a 1:1 ratio after informed consent.
Participants in both groups will be intubated in the same circumstances. The procedure include a midazolam anxiolysis, a rapid sequence induction without cricoid pressure of predefined dosing of remifentanil, propofol and rocuronium and monitoring of an adequate muscles paralysis and dept of anesthesia.
Anesthesiologists will intubate in both groups using specific material: McGRATH videolaryngoscope with X-Blade, 8 mm endotracheal tube (ETT) for men or 7 mm for women and the Glidescope videolaryngoscope stylet inside the ETT.
The experimental group will differ from the control group by application of the VACCIN box over the participant's head through which the anesthesiologist will intubate. Proper installation and removal of the VACCIN box will also be evaluated.
Intubations will only be done by anesthesiologists to assure patient safety. Each anesthesiologist will be assigned a practice session using the VACCIN box on an intubation mannequin prior to the study.
Time measurements throughout the procedure will be taken to obtain the outcomes measures. Vital signs, TOF, NOL index and BISpectral index monitoring are part of the protocol in order to assure an adequate anesthesia induction prior and after intubation.
A total of 60 participants will be enrolled in the study (30 in each group). Sample size calculation was based on local intubation mean time with COVID-19 pandemic protocols of 45 seconds with a 15 seconds standard deviation (SD). 26 participants per group are needed considering that an intubation time that is 30% or more over the current mean would imply that the VACCIN Box slowed down the intubation with an assumed SD of 15 seconds, a significance level of 5% and power of 90%. Sample size per group was rounded up to 30 in order to overcome possible exclusion or loss.
The primary outcome, the intubation time in seconds, will be tested for normal distribution with a D'Agostino-Pearson omnibus normality test and analyzed using a Two-tailed Student t test for unpaired groups. The intubation time will be presented as mean and standard deviation [SD].
For the secondary outcomes, the χ2 test will be used for the comparisons of the success rate of intubation at first laryngoscopy. The Mann-Whitney U test will be used to compare the ease of intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VACCIN box group | Experimental | Device: VACCIN boxThe anesthesiologist will intubate the participants in the VACCIN box group while using the VACCIN box that will be placed over the participants' head. |
| Control group | No intervention | –Enrolled participants in the control group will be intubated without the use of the VACCIN intubation box (standard anesthesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery requiring general anesthesia with tracheal intubation
- ASA status I, II or III
- Good understanding of English or French
Key exclusion criteria (13 listed)
- Known difficult airway
- Anticipated difficult airway (Mallampati ≥ 3, oral opening < 2.5 cm, thyromental distance < 6 cm, limited cervical mobility, significant abnormality of the upper respiratory tract, history of major surgery on airway or cervical area)
- COVID-19 positive or unknown status
- Rapid sequence contraindication
- Presence of antibiotic-resistant bacteria requiring a form of additional protective equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VACCIN boxThe VACCIN box is a translucid box that can be placed over the patient's head. It has entry holes on the front and the side of the box in which nitrile gloves can be attached. The anesthesiologist can intubate with arms and hands inside the box. Its also has the capacity to create a negative pressure environment inside the box by connecting an air suction cable from the box to the OR medical aspiration line. | Device | VACCIN box group |
Primary outcome
Intubation time
Time frame: Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor
Seconds
10 secondary outcomes
Success rate of intubation at first laryngoscopy
Time frame: Immediately after the intubation
Ease of tracheal intubation
Time frame: Immediately after the intubation
VACCIN box installation time
Time frame: The VACCIN box installation time will correspond to the time interval in the experimental group between the start of the VACCIN box placement over the participant's head to the removal of the preoxygenation mask before intubation.
VACCIN box removal time
Time frame: The VACCIN box removal time will correspond to the time interval in the experimental group between the initial detection of end-tidal CO2 on the anesthesia monitor to the complete removal of the VACCIN box.
Breach of air tightness
Time frame: Immediately after the intubation
Qualitative reviews on intubation with the VACCIN box
Time frame: Immediately after the intubation
Non-invasive blood pressure variations around tracheal intubation
Time frame: before, during and for 5 minutes after tracheal intubation
Heart rate variations around tracheal intubation
Time frame: before, during and for 5 minutes after tracheal intubation
NOL variation (NOL is an index without unit) around tracheal intubation
Time frame: before, during and for 5 minutes after tracheal intubation
Bispectral index (BIS) variation (BIS is an index without unit) around tracheal intubation
Time frame: before, during and for 5 minutes after tracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VACCIN box in people with Intubation, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Issam Tanoubi (514 252 3400 ext. 3426, i.tanoubi@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.