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

21 luglio 2022 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Anticipato)

60

Contatti e Sedi

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Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Descriptive analysis of the common tasks that could not be completed on PRESTO and mNIHSS (missing items)
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 luglio 2022

Completamento primario (Anticipato)

30 ottobre 2022

Completamento dello studio (Anticipato)

30 ottobre 2022

Date di iscrizione allo studio

Primo inviato

20 giugno 2022

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2022

Primo Inserito (Effettivo)

7 luglio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 luglio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2022

Ultimo verificato

1 luglio 2022

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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