NCT04156594

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

November 5, 2019

Last Update Submit

May 10, 2023

Conditions

Lung Diseases, ObstructivePostoperative ComplicationsCardiac Event

Keywords

self-assessmentpost operative pulmonary complicationExerciseTest

Outcome Measures

Primary Outcomes (1)

  • Postoperative pulmonary complications (PPC)

    European Perioperative Clinical Outcome (EPCO) definitions

    until hospital discharge up to 6 months after surgery

Secondary Outcomes (5)

  • Major Adverse Cardiac Events (MACE)

    until hospital discharge up to 6 months after surgery

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

    until hospital discharge up to 6 months after surgery

  • Duration of hospitalization (days)

    until hospital discharge up to 6 months after surgery

  • in-hospital mortality

    until hospital discharge up to 6 months after surgery

  • Length of stay in the intensive care unit (days)

    until hospital discharge up to 6 months after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for operations in general anesthesia, who present in the pre-assessment clinic of the University Medical Center Hamburg-Eppendorf during the study recruitment period, will be screened for eligibility.

You may qualify if:

  • years and older
  • Operations in general anesthesia

You may not qualify if:

  • \< 18 Years
  • Pregnancy
  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related 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.

    PMID: 23287892BACKGROUND

  • 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.

    PMID: 25058504BACKGROUND

  • 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.

    PMID: 28182564BACKGROUND

  • 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.

    PMID: 30070222BACKGROUND

MeSH Terms

Conditions

Lung Diseases, ObstructivePostoperative ComplicationsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • André Dankert, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

November 4, 2019

Primary Completion

February 11, 2022

Study Completion

February 17, 2023

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

DE(1)