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Feasibility of Stroke Screening Tools in Cardiac Surgery Patients (PESST-Cardiac)

21 de julho de 2022 atualizado por: Alana Flexman, University of British Columbia

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

60

Contactos e Locais

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Contato de estudo

Locais de estudo

    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 1Y6

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

At baseline patient screening:

  1. Patients who have severe cognitive impairment measured through the use of the three minute screening tool, Mini-Cog (<3 out of 5)
  2. Patient has limited ability to complete assessment at baseline
  3. Unable to read/speak English easily as we do not have the resources to translate our study materials into other languages
  4. Significant hearing/visual impairments as it would make it hard to complete the study
  5. 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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.

Assessment will be done 1 to 12 hours after extubation postoperatively (post-extubation day zero)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Descriptive analysis of the common tasks that could not be completed on PRESTO and mNIHSS (missing items)
Prazo: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Determining which items on the the stroke scales could not be completed at different time points around surgery
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.
Prazo: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
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.
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.
Prazo: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Determine which scales may screen positive for strokes at different time points around surgery
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)
Prazo: Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two
Determine which patient factors are associated with changes in stroke screening scores after surgery
Baseline prior to surgery, post-extubation day zero, post-extubation day one, post-extubation day two

Colaboradores e Investigadores

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de julho de 2022

Conclusão Primária (Antecipado)

30 de outubro de 2022

Conclusão do estudo (Antecipado)

30 de outubro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

20 de junho de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de julho de 2022

Primeira postagem (Real)

7 de julho de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de julho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de julho de 2022

Última verificação

1 de julho de 2022

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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