Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Completed

• Conditions: Lung Diseases, Obstructive; Postoperative Complications; Cardiac Event

• Registration Number: NCT04156594
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Primary Completion: 2022-02-11
• Study Completion: 2023-02-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

• 18 years and older
• Operations in general anesthesia

Exclusion Criteria

• < 18 Years
• Pregnancy
• Lack of cooperation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	until hospital discharge up to 6 months after surgery	European Perioperative Clinical Outcome (EPCO) definitions
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
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
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)

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany