The bedside investigation of pulmonary embolism diagnosis study: a double-blind randomized controlled trial comparing combinations of 3 bedside tests vs ventilation-perfusion scan for the initial investigation of suspected pulmonary embolism

Arch Intern Med. 2006 Jan 23;166(2):181-7. doi: 10.1001/archinte.166.2.181.

Abstract

Background: We sought to determine whether using combinations of 3 bedside tests (7-variable clinical model, non-enzyme-linked immunosorbent assay D-dimer test, and alveolar dead-space fraction) to exclude pulmonary embolism (PE) before diagnostic imaging was as safe as a standard strategy of starting with ventilation-perfusion (V/Q) scan.

Methods: In this double-blind, randomized, controlled equivalency trial, patients were randomized to initial bedside tests or to initial V/Q scan without bedside tests. Patients assigned to the bedside test group had a sham V/Q scan performed if at least 2 of 3 bedside test results were negative; otherwise, they underwent an actual V/Q scan. Further diagnostic management was determined by a blinded physician after V/Q scan. The primary outcome measure was recurrent venous thromboembolic events during 3 months among patients who were not taking anticoagulant agents after the initial investigations were completed.

Results: Four hundred fifty-eight consecutive adults with suspected PE were eligible for the study; 398 of 399 consenting and randomized patients completed the study. The follow-up venous thromboembolic event rate was 2.4% in the bedside test group vs 3.0% in the V/Q scan group (P = .76). Pulmonary embolism was excluded in 34% (67/199) of the bedside test group patients with at least 2 negative results on 3 bedside tests vs 18% (35/199) excluded using only the 7-variable clinical model and the D-dimer test.

Conclusion: Excluding PE with at least 2 negative results on 3 bedside tests safely eliminates the need for diagnostic imaging in 34% of patients with suspected PE.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Biomarkers / analysis
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis*
  • Humans
  • Male
  • Middle Aged
  • Point-of-Care Systems*
  • Predictive Value of Tests
  • Probability
  • Pulmonary Embolism / diagnosis*
  • Pulmonary Embolism / drug therapy
  • Pulmonary Embolism / mortality
  • Reference Values
  • Respiratory Dead Space*
  • Respiratory Function Tests
  • Risk Assessment
  • Sensitivity and Specificity
  • Survival Rate
  • Tomography, X-Ray Computed / methods*
  • Ventilation-Perfusion Ratio*

Substances

  • Biomarkers
  • Fibrin Fibrinogen Degradation Products
  • fibrin fragment D