SCOPE Trial

• Research type

  Research Study

• Full title

  SCOPE Trial (Study of etCO2 in the Diagnosis of Pulmonary Embolism)

• IRAS ID

  220453

• Contact name

  Mojgan Najafzadeh

• Contact email

  m.najafzadeh1@bradford.ac.uk

• Sponsor organisation

  Bradford Teaching Hospitals NHS Foundation Trust

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 0 months, 31 days

• Research summary

  OBJECTIVES: To determine whether the measurement of etCO2 in patients suspected of PE can be reliably used to diagnose pulmonary embolism.

  TRIAL DESIGN: prospective, multi-centre, non-randomised head-to-head comparison with current best practice (Wells Score and D-Dimer assessed against CTPA or VQ.) This study involves a comparison of diagnostic pathways utilising an etCO2 value, compared to using the Wells Score and D-Dimer testing. The monitor and equipment will be provided free of charge by a company called MedTronic.

  PATIENT TYPE/NUMBERS: This will be a multicentre study in 3 centres across Yorkshire: Bradford, Halifax and Airedale. The aim is to recruit 1500 patients in 6 months. One arm of the study (pregnant patients only) will be extended until a total number of 1500 pregnant patients have been studied.

  ENDPOINTS:

  Primary Endpoint
  To establish if etCO2 improves the sensitivity and specificity of diagnostic testing for pulmonary embolism against current best practice (D-Dimer combined with Wells Score)

  Secondary Endpoints
  1. To determine to what extent etCO2 is reliant on pre-test probability (Wells Score)
  2. Establish the accuracy, reproducibility and reliability of end-tidal CO2 as a diagnostic test for Pulmonary Embolism with prospective data.
  3. Establish the accuracy, reproducibility, reliability and feasibility in defined subgroups – pregnancy, post-operative, smokers and those with cardiorespiratory co-morbidities (COPD, CAP, LVF etc)
  4. Estimate of Cost of etCO2 vs. D-Dimer testing.
  5. Estimate of Door-to-diagnosis time reduction
  6. Estimate of Admission and LOS reduction
  7. Estimate of Anticoagulant drug reduction
  8. Estimate of CTPA reduction

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  17/YH/0003

• Date of REC Opinion

  19 Jul 2017

• REC opinion

  Further Information Favourable Opinion