SCEPTER-III Clinical Trials to Evaluate Patient-Centered Outcomes - - PowerPoint PPT Presentation

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SCEPTER-III Clinical Trials to Evaluate Patient-Centered Outcomes - - PowerPoint PPT Presentation

SCEPTER-III Clinical Trials to Evaluate Patient-Centered Outcomes of Sedation in Mechanically Ventilated Patients in the Adult ICU March 28-29, 2019 Washington, DC Pre-clinical testing Compound Discovery Phase 4 post marketing clinical


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Clinical Trials to Evaluate Patient-Centered Outcomes of Sedation in Mechanically Ventilated Patients in the Adult ICU March 28-29, 2019 Washington, DC

SCEPTER-III

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Phase 4 post marketing clinical trials Compound Discovery Pre-clinical testing Phase 1 -3 clinical trials FDA Approval

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Outcomes Data Collection (GCP) Clinical Trial Design

FDA Academic Clinical Researcher Pharma Public Practicing Clinician Health Care Systems

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Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER)

  • Two systematic reviews on Procedural Sedation

(adult and pediatric) published

  • Two consensus recommendations published on

Procedural Sedation (Efficacy and Safety)

  • Consensus conference on sedation for Adult ICU

patients in March

  • Future conference on sedation for Pediatric ICU

patients

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https://www.openanesthesia.org/article-of-the-month/

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Healthcare Quality Domains

Safe Timely Patient centered Effective Efficient Equitable

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  • Comfortable
  • No anxiety
  • No unpleasant recall
  • Prompt return to

baseline

  • No side effects (e.g.

PONV)

  • Rapid recovery & D/C
  • Optimal procedure
  • utcome
  • No airway

intervention or CV instability

  • Ease of sedation
  • Consistent sedation
  • Ease of procedure
  • Ideal conditions for

procedure

Patient Clinician

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Re Reade MC, Fi Finfer er S.

  • S. N En

Engl J J Med 2014;370:444-454. 454.

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