Skip to main content
OpenTrials
Completed

NCT Number: NCT04156594

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Operations in general anesthesia

Exclusion criteria

  • < 18 Years
  • Pregnancy
  • Lack of cooperation

Treatment and study plan

Primary outcomes

  1. Postoperative pulmonary complications (PPC)

    Time frame: until hospital discharge up to 6 months after surgery

    European Perioperative Clinical Outcome (EPCO) definitions

Secondary outcomes

  1. Major Adverse Cardiac Events (MACE)

    Time frame: until hospital discharge up to 6 months after surgery

    European Perioperative Clinical Outcome (EPCO) definitions

  2. 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

    New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses

  3. Duration of hospitalization (days)

    Time frame: until hospital discharge up to 6 months after surgery

    Duration of hospitalization (days)

  4. in-hospital mortality

    Time frame: until hospital discharge up to 6 months after surgery

    in-hospital mortality

  5. Length of stay in the intensive care unit (days)

    Time frame: until hospital discharge up to 6 months after surgery

    Length of stay in the intensive care unit (days)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: PRESELECT

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 7, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.