Cardiac Event, Lung Diseases, Obstructive, Postoperative Complications
Conditions
Keywords
self-assessment, post operative pulmonary complication, ExerciseTest
Brief summary
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
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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of limited exercise capacity in patients with COPD is predictive of PPC is suitable.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%).
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Operations in general anesthesia
Exclusion criteria
* \< 18 Years * Pregnancy * Lack of cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications (PPC) | until hospital discharge up to 6 months after surgery | European Perioperative Clinical Outcome (EPCO) definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | 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 | until hospital discharge up to 6 months after surgery | New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses |
| Duration of hospitalization (days) | until hospital discharge up to 6 months after surgery | Duration of hospitalization (days) |
| in-hospital mortality | until hospital discharge up to 6 months after surgery | in-hospital mortality |
| Length of stay in the intensive care unit (days) | until hospital discharge up to 6 months after surgery | Length of stay in the intensive care unit (days) |
Countries
Germany
Outcome results
None listed