Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Overview

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).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2020

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Major Adverse Cardiac Events (MACE)
    • Time Frame: 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
    • Time Frame: until hospital discharge up to 6 months after surgery
  • Duration of hospitalization (days)
    • Time Frame: until hospital discharge up to 6 months after surgery
  • in-hospital mortality
    • Time Frame: until hospital discharge up to 6 months after surgery
  • Length of stay in the intensive care unit (days)
    • Time Frame: until hospital discharge up to 6 months after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years and older
  • Operations in general anesthesia

Exclusion Criteria

  • < 18 Years
  • Pregnancy
  • Lack of cooperation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Provider of Information About this Clinical Study
    • Principal Investigator: André Dankert, MD, Principal Investigator – Universitätsklinikum Hamburg-Eppendorf
  • Overall Contact(s)
    • André Dankert, MD, +494015222817660, a.dankert@uke.de

References

Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499.

Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, López Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Eur Respir J. 2017 Mar 6;49(3). pii: 1700214. doi: 10.1183/13993003.00214-2017. Print 2017 Mar. Erratum in: Eur Respir J. 2017 Jun 22;49(6):.

Wijeysundera DN, Pearse RM, Shulman MA, Abbott TEF, Torres E, Ambosta A, Croal BL, Granton JT, Thorpe KE, Grocott MPW, Farrington C, Myles PS, Cuthbertson BH; METS study investigators. Assessment of functional capacity before major non-cardiac surgery: an international, prospective cohort study. Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/S0140-6736(18)31131-0.

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