Feasibility of the mNIHSS in Surgical Patients

NCT04044807 | Completed

• 1 other identifier: H19-01572
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Acute; Stroke, Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Completeness of mNIHSS

  Baseline prior to surgery, recovery room, postoperative day one, postoperative day two

• Time required to complete the mNIHSS

  Baseline prior to surgery, recovery room, postoperative day one, postoperative day two

• Acceptability of mNIHSS to patients

  Baseline prior to surgery, recovery room, postoperative day one, postoperative day two

Interventions

Modified National Institutes of Health Stroke Scale DIAGNOSTIC_TEST

Clinical tool used in the diagnosis of acute stroke developed by the National Institutes of Health, and modified for simplicity.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver General Hospital: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: August 6, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)