Stroke, AcuteNCT04044807
Feasibility of the mNIHSS in Surgical Patients
An observational study of Stroke, Acute and Stroke, Complication, run by University of British Columbia at 1 site in Canada.
Trial summary
This prospective observational study will be assessing whether it is practical and feasible to use a stroke screening tool (the modified NHISS, mNIHSS) in an adult surgical population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Complication
- What is being tested?
- Modified National Institutes of Health Stroke Scale
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2019to 1 Sep 2019
- 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 65 years and older
- All sexes
- Older adult
Study population: Patients will be recruited from the Vancouver General Hospital Anesthesia Consult Clinic (ACC) or the ward. We will include older adult patients (65 years or older) presenting for non-cardiac non-neurologic surgery under general anesthesia at Vancouver General Hospital with a minimum two-night stay in hospital.
Who may be able to join
- We will include older adult patients (65 years or older) presenting for non-cardiac non-neurologic surgery under general anesthesia at Vancouver General Hospital with a minimum two-night stay in hospital.
Who cannot join
- We will exclude patients undergoing procedures involving the major vasculature of the head and neck, as well as patients who are predicted to require postoperative ventilation or planned tracheostomy. Patients who are not able to read or speak English will be excluded, as well as patients with significant hearing or visual impairment that would make assessment unreliable. In order to complete the mNIHSS accurately, we will exclude patients with significant cognitive impairment suggestive of dementia (MoCA score 17 or less) or a diagnosis of dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of the Modified National Institutes for Health Stroke Scale to Screen for Stroke in Surgical Patients
This prospective observational study will be assessing whether it is practical and feasible to use a stroke screening tool (the modified NHISS, mNIHSS) in an adult surgical population. Perioperative stroke is an uncommon but devastating complication of surgery and previous research suggests that stroke symptoms may be missed in this population. This stroke screening tool has been used extensively in non-surgical patients but has not be used in non-cardiac surgical patients. Surgical patients have additional factors that may affect their ability to complete this assessment such as pain medications and sedatives, pain, and use of epidurals and nerve blocks. This study will involve a total of five testing sessions. The first will occur at the time of consent to screen for cognitive impairment via the Montreal Cognitive Assessment (MoCA), as part of our exclusion criteria. Then over the course of four subsequent visits, participants will be assessed on the mNIHSS to track for any changes before and after their procedure, as well as evaluate the real-life usability of the mNIHSS as a potential tool to screen for stroke in the surgical population.
Read the detailed description
Purpose \& Justification: Perioperative stroke is a potentially devastating complication that is currently poorly characterized with limited clinical tools available to detect and prevent its occurrence. To date only two stroke assessment scales have been applied to the perioperative setting, though none have been tested in non-cardiac, non-neurologic surgeries. 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, such as pain and drowsiness from medications. However, there is a modified simpler version of the NIHSS (mNIHSS) that has been shown to have improved reliability than the full version and reduced time requirement, thus making it preferable for perioperative stroke screening. To overcome the current gaps in knowledge and screening for risk of perioperative stroke, this prospective observational study will be assessing the feasibility of applying the mNIHSS in the surgical setting.
Primary Objective: To determine the change in mNIHSS score from baseline to immediately after surgery in the absence of diagnosed stroke in patients after surgery.
Secondary Objectives:
- To determine the components of the mNIHSS most likely to change following surgery;
- To determine the feasibility of administering the mNIHSS in surgical patients (e.g. acceptability, resources, length of time to complete, completeness).
- To determine the relationship between baseline MoCA score and ability to complete the mNIHSS screening after surgery
Research design: This is a prospective observational study involving five testing sessions. A cognitive assessment (MoCA) will be conducted at the time of consent to screen for any cognitive impairment. There will be 4 additional visits during which the mNIHSS will be administered to surgical patients pre and post-operatively.
Statistical Analysis:
Sample Size Calculation There is no specific data available on the application of the mNIHSS in our study population. We estimate that we will require a sample size of 21 patients, assuming a mean difference of 2 (standard deviation 3) points between pre- and post-operatively, an alpha error of 0.05 and power of 80%. Anticipating a 20% drop out rate, we will recruit 25 patients.
Statistical Analysis We will describe the patient population using mean (SD), median (IQR) and percentage as appropriate. The application of the mNIHSS will be described using percent completed for each question, and the time taken to complete the test at each time point (mean, SD).
The change in mNIHSS on postoperative days 0, 1 and 2 will be compared to baseline using a Wilcoxon Signed Ranks test for matched pairs.
All tests will be two-sided with a p-value less than 0.05 considered statistically significant. All statistical analysis will be done using STATA 12.1 (StataCorp, Texas, USA).
- Conditions
- Stroke, Acute, Stroke, Complication
- Being tested
- Modified National Institutes of Health Stroke Scale
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mNIHSS score
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: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Secondary outcomes (3)
Completeness of mNIHSS
Ability of patients to complete the mNIHSS at different time points around surgery
Measured: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Time required to complete the mNIHSS
Time to complete the mNIHSS at different time points around surgery
Measured: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Acceptability of mNIHSS to patients
Qualitative feedback from patients about the acceptability of the mNIHSS to surgical patients
Measured: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start6 Aug 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver General Hospital
- Responsible party
- Principal investigator, Alana Flexman, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044807
- Sponsor's protocol ID
- H19-01572
- Status last verified
- Sep 2019
- First submitted
- 2 Aug 2019
- Last updated
- 25 Sep 2019
- 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Modified National Institutes for Health Stroke Scale to Screen for Stroke in Surgical Patients
- ClinicalTrials.gov ID
- NCT04044807
- Acronym / sponsor ID
- H19-01572
- Conditions
- Stroke, Acute, Stroke, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver General Hospital
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 5 Aug 2019 (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.
This prospective observational study will be assessing whether it is practical and feasible to use a stroke screening tool (the modified NHISS, mNIHSS) in an adult surgical population. Perioperative stroke is an uncommon but devastating complication of surgery and previous research suggests that stroke symptoms may be missed in this population. This stroke screening tool has been used extensively in non-surgical patients but has not be used in non-cardiac surgical patients. Surgical patients have additional factors that may affect their ability to complete this assessment such as pain medications and sedatives, pain, and use of epidurals and nerve blocks. This study will involve a total of five testing sessions. The first will occur at the time of consent to screen for cognitive impairment via the Montreal Cognitive Assessment (MoCA), as part of our exclusion criteria. Then over the course of four subsequent visits, participants will be assessed on the mNIHSS to track for any changes before and after their procedure, as well as evaluate the real-life usability of the mNIHSS as a potential tool to screen for stroke in the surgical population.
Detailed description
Purpose \& Justification: Perioperative stroke is a potentially devastating complication that is currently poorly characterized with limited clinical tools available to detect and prevent its occurrence. To date only two stroke assessment scales have been applied to the perioperative setting, though none have been tested in non-cardiac, non-neurologic surgeries. 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, such as pain and drowsiness from medications. However, there is a modified simpler version of the NIHSS (mNIHSS) that has been shown to have improved reliability than the full version and reduced time requirement, thus making it preferable for perioperative stroke screening. To overcome the current gaps in knowledge and screening for risk of perioperative stroke, this prospective observational study will be assessing the feasibility of applying the mNIHSS in the surgical setting.
Primary Objective: To determine the change in mNIHSS score from baseline to immediately after surgery in the absence of diagnosed stroke in patients after surgery.
Secondary Objectives:
- To determine the components of the mNIHSS most likely to change following surgery;
- To determine the feasibility of administering the mNIHSS in surgical patients (e.g. acceptability, resources, length of time to complete, completeness).
- To determine the relationship between baseline MoCA score and ability to complete the mNIHSS screening after surgery
Research design: This is a prospective observational study involving five testing sessions. A cognitive assessment (MoCA) will be conducted at the time of consent to screen for any cognitive impairment. There will be 4 additional visits during which the mNIHSS will be administered to surgical patients pre and post-operatively.
Statistical Analysis:
Sample Size Calculation There is no specific data available on the application of the mNIHSS in our study population. We estimate that we will require a sample size of 21 patients, assuming a mean difference of 2 (standard deviation 3) points between pre- and post-operatively, an alpha error of 0.05 and power of 80%. Anticipating a 20% drop out rate, we will recruit 25 patients.
Statistical Analysis We will describe the patient population using mean (SD), median (IQR) and percentage as appropriate. The application of the mNIHSS will be described using percent completed for each question, and the time taken to complete the test at each time point (mean, SD).
The change in mNIHSS on postoperative days 0, 1 and 2 will be compared to baseline using a Wilcoxon Signed Ranks test for matched pairs.
All tests will be two-sided with a p-value less than 0.05 considered statistically significant. All statistical analysis will be done using STATA 12.1 (StataCorp, Texas, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients will be recruited from the Vancouver General Hospital Anesthesia Consult Clinic (ACC) or the ward. We will include older adult patients (65 years or older) presenting for non-cardiac non-neurologic surgery under general anesthesia at Vancouver General Hospital with a minimum two-night stay in hospital.
Key inclusion criteria (1 listed)
- We will include older adult patients (65 years or older) presenting for non-cardiac non-neurologic surgery under general anesthesia at Vancouver General Hospital with a minimum two-night stay in hospital.
Key exclusion criteria (1 listed)
- We will exclude patients undergoing procedures involving the major vasculature of the head and neck, as well as patients who are predicted to require postoperative ventilation or planned tracheostomy. Patients who are not able to read or speak English will be excluded, as well as patients with significant hearing or visual impairment that would make assessment unreliable. In order to complete the mNIHSS accurately, we will exclude patients with significant cognitive impairment suggestive of dementia (MoCA score 17 or less) or a diagnosis of dementia.
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 | – |
Primary outcome
Total mNIHSS score
Time frame: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
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.
3 secondary outcomes
Completeness of mNIHSS
Time frame: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Time required to complete the mNIHSS
Time frame: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Acceptability of mNIHSS to patients
Time frame: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 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: finished, as of the sponsor's last update on 25 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total mNIHSS score (time frame: Baseline prior to surgery, recovery room, postoperative day one, postoperative day two). 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 25 Sep 2019.