Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Postoperative Complications Clinical Trial

— PRESELECT  

Official title:

Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156594
• Other study ID #: PV7061
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: February 17, 2023

Study information

• Verified date: May 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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 Our unpublished data show that a subjective self-assessment of "limited exercise capacity" in patients with COPD is predictive of PPC is suitable.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5500
• Est. completion date: February 17, 2023
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older
• Operations in general anesthesia

Exclusion Criteria:

• < 18 Years
• Pregnancy
• Lack of cooperation

Related Conditions & MeSH terms

• Cardiac Event
• Lung Diseases
• Lung Diseases, Obstructive
• Postoperative Complications

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez 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):1700214. doi: 10.1183/13993003.00214-2017. Print 2017 Mar. Erratum In: Eur Respir J. 2017 Jun 22;49(6): — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pulmonary complications (PPC)	European Perioperative Clinical Outcome (EPCO) definitions	until hospital discharge up to 6 months after surgery
Secondary	Major Adverse Cardiac Events (MACE)	European Perioperative Clinical Outcome (EPCO) definitions	until hospital discharge up to 6 months after surgery
Secondary	New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses	New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses	until hospital discharge up to 6 months after surgery
Secondary	Duration of hospitalization (days)	Duration of hospitalization (days)	until hospital discharge up to 6 months after surgery
Secondary	in-hospital mortality	in-hospital mortality	until hospital discharge up to 6 months after surgery
Secondary	Length of stay in the intensive care unit (days)	Length of stay in the intensive care unit (days)	until hospital discharge up to 6 months after surgery