Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Study Overview
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Brief Summary
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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).

Detailed Description
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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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of limited exercise capacity in patients with COPD is predictive of PPC is suitable. Objectives: Development of a self-assessment questionnaire as part of a Delphi trial Validation of the self-assessment questionnaire Methodology: 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%).

Official Title
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Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Conditions
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Lung Diseases, Obstructive, Postoperative Complications, Cardiac Event

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Operations in general anesthesia Exclusion Criteria: < 18 Years Pregnancy Lack of cooperation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications (PPC) | European Perioperative Clinical Outcome (EPCO) definitions | until hospital discharge up to 6 months after surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-assessment, post operative pulmonary complication, ExerciseTest