NCT04156594

Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,500 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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%).

Conditions

• Lung Diseases, Obstructive
• Postoperative Complications
• Cardiac Event

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-02-11
• Completion: 2023-02-17
• First posted: 2019-11-07
• Last updated: 2023-05-11

Locations

1 site across 1 country: Germany