Feasibility of Stroke Screening Tools in Cardiac Surgery Patients

NCT05447728 | Unknown

• 1 other identifier: H22-01027
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Acute; Stroke, Complication; Surgical Complication

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  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)

  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.

  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.

  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)

  Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation 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.

PRESTO DIAGNOSTIC_TEST

The PRESTO study is a group of 8 pre-hospital stroke scales used to detect large vessel occlusion strokes.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients undergoing scheduled cardiac surgery (open heart) procedures at St. Paul's Hospital.

You may not qualify if:

• 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:
• a) They require a tracheostomy or 5 days or more of mechanical ventilation

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Alana Flexman, MD

CONTACT

604-806-8337; aflexman@providencehealth.bc.ca

Study Design

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

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 7, 2022
• Study Start: July 4, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)