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APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

A

Andrew Tomas Reisner

Status and phase

Enrolling
Phase 1

Conditions

Wounds and Injuries

Treatments

Device: APPRAISE Trauma Clinical Decision Support System

Study type

Interventional

Funder types

Other

Identifiers

NCT06121661
2022P001136

Details and patient eligibility

About

This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:

  1. Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
  2. Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
  3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult (≥18 yrs) Emergency Department (ED) patient
  • Triaged to the "Acute" area of the ED. (The "Acute" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).
  • Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).

Exclusion criteria

  • Prisoners
  • Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound
  • Patients wearing an "EFIC Opt-Out" bracelet
  • Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR [lawfully authorized representative] of the patient).

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

APPRAISE cases
Experimental group
Description:
Trauma patients for which APPRAISE system was used
Treatment:
Device: APPRAISE Trauma Clinical Decision Support System

Trial contacts and locations

1

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Central trial contact

Iain Kehoe

Data sourced from clinicaltrials.gov

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