Preoperative Self-assessment for Cardio-pulmonary Risk Stratification


This prospective study intends to development and validation a patient self-assessment questionnaire. The aim of the self-assessment, by questionnaire, is to estimate the risk of postoperative pulmonary complications (PPC).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2020

Detailed Description

PPC are common adverse events operative patients. Existing concepts of pulmonary risk evaluation are based on complex risk scores, preoperative apparatus examinations, laboratory parameters and medical findings. The significance of apparatus diagnostics for the preoperative Pulmonary risk evaluation is highly controversial and guidelines recommend a reluctant use. A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic risk assessment. In a large study it could be shown that a subjective self-assessment of physical performance by means of a structured questionnaire (DASI), in contrast to a subjective medical assessment, suitable for predicting perioperative cardiac events. Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.


- Development of a self-assessment questionnaire as part of a Delphi trial

- Validation of the self-assessment questionnaire


Prospective observational, case control study of 5000 patients undergoing surgery in general anesthesia (estimated enrollment of 5500 patients with a dropout rate of approximately 10%).

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pulmonary complications (PPC)
    • Time Frame: until hospital discharge up to 6 months after surgery
    • European Perioperative Clinical Outcome (EPCO) definitions

Secondary Measures

  • Major Adverse Cardiac Events (MACE)
    • Time Frame: until hospital discharge up to 6 months after surgery
    • European Perioperative Clinical Outcome (EPCO) definitions
  • New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses
    • Time Frame: until hospital discharge up to 6 months after surgery
  • Duration of hospitalization (days)
    • Time Frame: until hospital discharge up to 6 months after surgery
  • in-hospital mortality
    • Time Frame: until hospital discharge up to 6 months after surgery
  • Length of stay in the intensive care unit (days)
    • Time Frame: until hospital discharge up to 6 months after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years and older
  • Operations in general anesthesia

Exclusion Criteria

  • < 18 Years
  • Pregnancy
  • Lack of cooperation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Provider of Information About this Clinical Study
    • Principal Investigator: André Dankert, MD, Principal Investigator – Universitätsklinikum Hamburg-Eppendorf
  • Overall Contact(s)
    • André Dankert, MD, +494015222817660,


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