Stroke, AcutePESST-CardiacNCT05447728
Feasibility of Stroke Screening Tools in Cardiac Surgery Patients
An observational study of Stroke, Acute and Stroke, Complication, run by University of British Columbia at 1 site in Canada.
Trial summary
Patients undergoing cardiac surgery have a higher risk of postoperative stroke than patients undergoing non-cardiac surgery. Our ability to detect postoperative stroke in this population lags behind other postoperative complications which impacts outcomes for patients eligible for medical intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute, Stroke, Complication, Surgical Complication
- What is being tested?
- Modified National Institutes of Health Stroke Scale and PRESTO
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2022to 30 Oct 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients will be recruited from the St. Paul's Hospital Pre-Admission Clinic or the ward. We will include all patients presenting for open heart cardiac surgery St. Paul's Hospital.
Who may be able to join
- Patients undergoing scheduled cardiac surgery (open heart) procedures at St. Paul's Hospital.
Who cannot join
- At baseline patient screening:
- Patients who have severe cognitive impairment measured through the use of the three minute screening tool, Mini-Cog (<3 out of 5)
- Patient has limited ability to complete assessment at baseline
- Unable to read/speak English easily as we do not have the resources to translate our study materials into other languages
- Significant hearing/visual impairments as it would make it hard to complete the study
- Critical state before surgery with high probability of death within 24 hours
- After cardiac surgery, patients will be removed from further data collection if:
- They require a tracheostomy or 5 days or more of mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Alana Flexman, MD, 604-806-8337, aflexman@providencehealth.bc.ca
About this study
Official title: Perioperative Stroke Screening Tools in Cardiac Surgery (PESST-Cardiac): A Pilot Study
Patients undergoing cardiac surgery have a higher risk of postoperative stroke than patients undergoing non-cardiac surgery. Our ability to detect postoperative stroke in this population lags behind other postoperative complications which impacts outcomes for patients eligible for medical intervention. Screening tools have been successful in detecting prehospital stroke with good accuracy, but these tools have not been validated in a postoperative setting. The aim of this pilot study is to use determine the feasibility of using prehospital stroke scales in a post-cardiac surgery population, identify barriers for scale completion, and determine non-stroke factors that may affect screening scores.
Read the detailed description
Purpose and Justification: Perioperative stroke is a cerebrovascular event that occurs after surgery and is a potentially devastating complication that affects between 1-2% of cardiac surgery patients. Despite the potential impact of perioperative stroke, there is a lack of clinical tools validated to screen for stroke in the cardiac surgery population. To date only two stroke assessment scales have been applied to the perioperative setting. One of those assessments, the National Institutes of Health Stroke Scale (NIHSS), is lengthy and may be impractical in the surgical setting. This is further complicated by several factors potentially existing in surgical patients that may alter the assessment. For instance, drowsiness and administration of pain medications may affect consciousness, while pain itself may impede motor assessment. However, there are simpler, more targeted, screening tools that are reliable in detecting large artery strokes and require less time to complete, making them more preferable for perioperative stroke screening. Prehospital Triage of Patients with Suspected Stroke (PRESTO) is a combination of eight screening tools that individually have good reliability. However, none of these have been tested in a perioperative setting. The modified NIHSS (mNIHSS) is a shortened version of the NIHSS that is easier to administer and still maintains good ability to detect strokes. The investigators must assess the feasibility of these tools in surgical settings to improve perioperative stroke screening.
Research Design: Prospective observational cohort study.
Primary Objective: Determine feasibility of larger observational study to determine sensitivity and specificity of different stroke screening tools, PRESTO and mNIHSS, to predict perioperative stroke after cardiac surgery.
Sample Size Calculation: This is a pilot study to assess the feasibility of using the eight tools embedded within PRESTO. Preliminary data with a sample size of 25 was adequate in assessing the feasibility of mNIHSS in post-surgical patients. As there are no prior studies that have used PRESTO in post-cardiac surgery populations, the investigators decided to use a sample of convenience; the investigators anticipate sample size of 50 will be able to answer our study objectives. Factoring a 20% loss to follow up, the investigators will recruit a total of 60 patients at an estimated recruitment rate of 10 patients/week for 6 weeks.
Statistical Analysis: Participant characteristics will be described using means and standard deviations for continuous data and proportions (%) for categorical data. the investigators will explore changes in PRESTO and mNIHSS score from baseline over the study time points using a generalized estimating equation to account for repeated measures across multiple time points, with further inclusion of potential predictors of change in score (last sedation, age, Mini-Cog). For the co-primary feasibility outcomes, the investigators will calculate 95% confidence intervals. Multivariable regression model will be used to assess for predictors associated with large detectable changes in post op assessment scores.
- Conditions
- Stroke, Acute, Stroke, Complication, Surgical Complication
- Being tested
- Modified National Institutes of Health Stroke Scale, PRESTO
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified National Institutes of Health Stroke ScaleDiagnostic test
Clinical tool used in the diagnosis of acute stroke developed by the National Institutes of Health, and modified for simplicity.
PRESTODiagnostic test
The PRESTO study is a group of 8 pre-hospital stroke scales used to detect large vessel occlusion strokes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of larger observational study to determine sensitivity and specificity of different stroke screening tools, PRESTO and mNIHSS, to predict perioperative stroke after cardiac surgery
Feasibility is defined as:
- Recruitment rate of >75% for eligible patients
- Minimal missingness of tasks completed on the PRESTO and mNIHSS (<10%)
- Able to administer PRESTO and mNIHSS components at the required time points >75% of the time
PRESTO is a group of 8 pre-hospital stroke scales that are combined into a simple 9 item tool. Each scale uses their own scoring system and cut points that count as a positive stroke screen.
The modified National Institutes for Health Stroke Scale (mNIHSS) is a modified version of the NIHSS used widely in the clinical assessment of stroke patients. The The mNIHSS contains 11 items with a possible range of scores from 0 (best) to 31 (worse). Each of the 11 items provides in a subscore ranging from 0 (normal) to 2-4 points, and the total score is a sum of all subscores.
Measured: Assessment will be done 1 to 12 hours after extubation postoperatively (post-extubation day zero)
Secondary outcomes (4)
Descriptive analysis of the common tasks that could not be completed on PRESTO and mNIHSS (missing items)
Determining which items on the the stroke scales could not be completed at different time points around surgery
Measured: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Identifying barriers to completing task, participant feedback, and clinician feedback.
Determining the reasons behind the missing tasks. Obtaining feedback from the participants and clinicians in a likert scales as well as an open text box.
Measured: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Determine the percent of participants that meet criteria for a positive screen for a given screening tool.
Determine which scales may screen positive for strokes at different time points around surgery
Measured: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Identify relevant predictors of change in stroke screening scores following surgery (e.g. baseline cognitive functioning, time since extubation, time since last pain/sedative medication, delirium)
Determine which patient factors are associated with changes in stroke screening scores after surgery
Measured: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start4 Jul 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Flexman, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447728
- Sponsor's protocol ID
- H22-01027
- Acronym
- PESST-Cardiac
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 26 Jul 2022
- 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 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Stroke Screening Tools in Cardiac Surgery (PESST-Cardiac): A Pilot Study
- ClinicalTrials.gov ID
- NCT05447728
- Acronym / sponsor ID
- PESST-Cardiac / H22-01027
- Conditions
- Stroke, Acute, Stroke, Complication, Surgical Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 7 Jul 2022 (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.
Patients undergoing cardiac surgery have a higher risk of postoperative stroke than patients undergoing non-cardiac surgery. Our ability to detect postoperative stroke in this population lags behind other postoperative complications which impacts outcomes for patients eligible for medical intervention. Screening tools have been successful in detecting prehospital stroke with good accuracy, but these tools have not been validated in a postoperative setting. The aim of this pilot study is to use determine the feasibility of using prehospital stroke scales in a post-cardiac surgery population, identify barriers for scale completion, and determine non-stroke factors that may affect screening scores.
Detailed description
Purpose and Justification: Perioperative stroke is a cerebrovascular event that occurs after surgery and is a potentially devastating complication that affects between 1-2% of cardiac surgery patients. Despite the potential impact of perioperative stroke, there is a lack of clinical tools validated to screen for stroke in the cardiac surgery population. To date only two stroke assessment scales have been applied to the perioperative setting. One of those assessments, the National Institutes of Health Stroke Scale (NIHSS), is lengthy and may be impractical in the surgical setting. This is further complicated by several factors potentially existing in surgical patients that may alter the assessment. For instance, drowsiness and administration of pain medications may affect consciousness, while pain itself may impede motor assessment. However, there are simpler, more targeted, screening tools that are reliable in detecting large artery strokes and require less time to complete, making them more preferable for perioperative stroke screening. Prehospital Triage of Patients with Suspected Stroke (PRESTO) is a combination of eight screening tools that individually have good reliability. However, none of these have been tested in a perioperative setting. The modified NIHSS (mNIHSS) is a shortened version of the NIHSS that is easier to administer and still maintains good ability to detect strokes. The investigators must assess the feasibility of these tools in surgical settings to improve perioperative stroke screening.
Research Design: Prospective observational cohort study.
Primary Objective: Determine feasibility of larger observational study to determine sensitivity and specificity of different stroke screening tools, PRESTO and mNIHSS, to predict perioperative stroke after cardiac surgery.
Sample Size Calculation: This is a pilot study to assess the feasibility of using the eight tools embedded within PRESTO. Preliminary data with a sample size of 25 was adequate in assessing the feasibility of mNIHSS in post-surgical patients. As there are no prior studies that have used PRESTO in post-cardiac surgery populations, the investigators decided to use a sample of convenience; the investigators anticipate sample size of 50 will be able to answer our study objectives. Factoring a 20% loss to follow up, the investigators will recruit a total of 60 patients at an estimated recruitment rate of 10 patients/week for 6 weeks.
Statistical Analysis: Participant characteristics will be described using means and standard deviations for continuous data and proportions (%) for categorical data. the investigators will explore changes in PRESTO and mNIHSS score from baseline over the study time points using a generalized estimating equation to account for repeated measures across multiple time points, with further inclusion of potential predictors of change in score (last sedation, age, Mini-Cog). For the co-primary feasibility outcomes, the investigators will calculate 95% confidence intervals. Multivariable regression model will be used to assess for predictors associated with large detectable changes in post op assessment scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited from the St. Paul's Hospital Pre-Admission Clinic or the ward. We will include all patients presenting for open heart cardiac surgery St. Paul's Hospital.
Key inclusion criteria (1 listed)
- Patients undergoing scheduled cardiac surgery (open heart) procedures at St. Paul's Hospital.
Key exclusion criteria (8 listed)
- Patients who have severe cognitive impairment measured through the use of the three minute screening tool, Mini-Cog (<3 out of 5)
- Patient has limited ability to complete assessment at baseline
- Unable to read/speak English easily as we do not have the resources to translate our study materials into other languages
- Significant hearing/visual impairments as it would make it hard to complete the study
- Critical state before surgery with high probability of death within 24 hours
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 |
|---|---|---|
| Modified National Institutes of Health Stroke ScaleClinical tool used in the diagnosis of acute stroke developed by the National Institutes of Health, and modified for simplicity. | Diagnostic test | – |
| PRESTOThe PRESTO study is a group of 8 pre-hospital stroke scales used to detect large vessel occlusion strokes. | Diagnostic test | – |
Primary outcome
Determine feasibility of larger observational study to determine sensitivity and specificity of different stroke screening tools, PRESTO and mNIHSS, to predict perioperative stroke after cardiac surgery
Time frame: Assessment will be done 1 to 12 hours after extubation postoperatively (post-extubation day zero)
Feasibility is defined as: 1. Recruitment rate of >75% for eligible patients 2. Minimal missingness of tasks completed on the PRESTO and mNIHSS (<10%) 3. Able to administer PRESTO and mNIHSS components at the required time points >75% of the time PRESTO is a group of 8 pre-hospital stroke scales that are combined into a simple 9 item tool. Each scale uses their own scoring system and cut points that count as a positive stroke screen. The modified National Institutes for Health Stroke Scale (mNIHSS) is a modified version of the NIHSS used widely in the clinical assessment of stroke patients. The The mNIHSS contains 11 items with a possible range of scores from 0 (best) to 31 (worse). Each of the 11 items provides in a subscore ranging from 0 (normal) to 2-4 points, and the total score is a sum of all subscores.
4 secondary outcomes
Descriptive analysis of the common tasks that could not be completed on PRESTO and mNIHSS (missing items)
Time frame: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Identifying barriers to completing task, participant feedback, and clinician feedback.
Time frame: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Determine the percent of participants that meet criteria for a positive screen for a given screening tool.
Time frame: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Identify relevant predictors of change in stroke screening scores following surgery (e.g. baseline cognitive functioning, time since extubation, time since last pain/sedative medication, delirium)
Time frame: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- 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?
An observational study of Stroke, Acute and Stroke, Complication, run by University of British Columbia 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 1 inclusion and 8 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 26 Jul 2022. 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 Alana Flexman, MD (604-806-8337, aflexman@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine feasibility of larger observational study to determine sensitivity and specificity of different stroke screening tools, PRESTO and mNIHSS, to predict perioperative stroke after cardiac surgery (time frame: Assessment will be done 1 to 12 hours after extubation postoperatively (post-extubation day zero)). 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 26 Jul 2022.