Frequently Asked Questions 

Can a single institution/hospital act as 2 (or more) sites?

Yes, a single institution/hospital can have 2 or more sites. However, a separate survey needs to be filled out for each site. For example, if you plan on having both ICU and Anesthesia Locations/OR, one survey needs to be done for ICU and another separate survey needs to be for Anesthesia Locations/OR.  

Can we have two separate ICUs (e.g., CVICU and MSICU)?

It depends on your structure. You can combine the two to have cumulative 50 patients if possible. If they are too distinct and you can reach 50 patients for each ICU, then we would recommend them as two separate units/sites. This would mean you would need to complete two different surveys for the two ICUs.

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Can we enroll more than 50 patients per site? 

The maximum amount of patients that can be enrolled are 50 per site/unit. For example, if you are including both ICU and OR for your institution, then ICU will have a cap of 50 patients and the OR will have a separate cap of 50 patients. 

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Do we need to have 50 patients in order to participate for this study?

If your site/unit does not reach the maximum target of 50 patients within the two-week enrollment period, it would not impact your ability to participate in the study.   

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Can we do more than 2 weeks?

As this study is enrolling different kinds of centres, we want to be fair to all of them, whether they are a busy academic hospital that can get the 50 cases within 3 days or a community hospital that takes the full 2 weeks to get these 50 patients. Hence, the cap is 50 patients for each site/unit and the enrollment window cannot be more than 2 weeks. 

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What if our site enrolls the 50 patients in less than the 2-week period?

If your site/unit reaches the 50 patients in less than 2 weeks, then enrollment can be stopped. This is because only a maximum of 50 patients can be enrolled per site/unit.

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Our research team may not be able to support if data collection is required for extubations that occur after hours or on the weekend. Is it acceptable for us to capture the 50 extubations for any in-hours intubations that occur?

Due to the nature of the study, we will need to have details of consecutive extubations. This approach would reduce the risk of bias and allow to capture cases that may be at higher risk. Therefore, after hours and weekends will need to be included.

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How and when will the 2 week period be allocated to a centre?

It would depend on factors such as when your site gets ethics approval, the contract agreement signed, and site activation. When we get closer to site activation, we could potentially discuss preferred start dates or timeline. There may be some flexibility for the 2-week period selection.

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After the ethics approval is provided and the agreement is signed, can we start at once?

No, it is not possible to start at once. This is because there are Site Activation documents and materials required from a site's end. There is also the process of creating and issuing REDCap accounts (multi-step process). Overall, this combined process can take around 3 weeks on average. 

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Is the study pragmatic in nature, collecting data that is routinely charted, or are sites expected to implement new workflows or checklists for gathering values that might not be routinely charted?

The study is pragmatic in nature and the data that needs to be collected should all be available from the medical charts. However, please bear in mind it would vary from site to site and their infrastructure. If you do not routinely collect/chart a data point that is mentioned (e.g., patient position or who is in attendance at extubation), we would suggest having a workflow/form present to ensure that those values are collected for that 2-week enrollment period.

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What is the source of funding for this study?

The source of funding is from Canadian Institutes of Health Research (CIHR). The project grant we applied and were provided funding for was named: Project Grant: Fall 2023 and Spring 2024 (2023-09-14). The link for CIHR funding opportunities is as follows: https://cihr-irsc.gc.ca/e/49051.html

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​Who is the Sponsor for this study?

The sponsor is:

Dr. Matteo Parotto, MD, University Health Network (UHN)

Head of Interdepartmental Centre for Critical Care Medicine

Toronto General Hospital, Toronto, ON, Canada

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What is the site funding/budget?

The funding available is $2000 CAD for start-up and $125 CAD per patient that data entry is completed for. Please note that funding is not available for indirect/overhead costs.