Stroke, Acute Clinical Trial
Official title:
Feasibility of the Modified National Institutes for Health Stroke Scale to Screen for Stroke in Surgical Patients
NCT number | NCT04044807 |
Other study ID # | H19-01572 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 6, 2019 |
Est. completion date | September 1, 2019 |
Verified date | September 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Vancouver General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline prior to surgery, recovery room, postoperative day one, postoperative day two | |
Secondary | Completeness of mNIHSS | Ability of patients to complete the mNIHSS at different time points around surgery | Baseline prior to surgery, recovery room, postoperative day one, postoperative day two | |
Secondary | Time required to complete the mNIHSS | Time to complete the mNIHSS at different time points around surgery | Baseline prior to surgery, recovery room, postoperative day one, postoperative day two | |
Secondary | Acceptability of mNIHSS to patients | Qualitative feedback from patients about the acceptability of the mNIHSS to surgical patients | Baseline prior to surgery, recovery room, postoperative day one, postoperative day two |
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