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Lung Diseases, ObstructivePRESELECTNCT04156594

Preoperative Self-assessment for Cardio-pulmonary Risk Stratification

An observational study of Lung Diseases, Obstructive and Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,500 participants
Where
1 siteGermany
Study dates
4 Nov 2019to 17 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 18 years and older
  • Operations in general anesthesia

Who cannot join

  • < 18 Years
  • Pregnancy
  • Lack of cooperation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

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).

Read the 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 A large prospective study (PREDICT, unpublished to date, NCT02566343) showed that lung function assessment in patients with COPD symptoms undergoing major non-cardiac surgery did not improve the anamnestic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%).

Keywords
self-assessment, post operative pulmonary complication, ExerciseTest
Medical subject headings
Lung Diseases, Obstructive, Postoperative Complications, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pulmonary complications (PPC)

    European Perioperative Clinical Outcome (EPCO) definitions

    Measured: until hospital discharge up to 6 months after surgery

Secondary outcomes (5)

  1. Major Adverse Cardiac Events (MACE)

    European Perioperative Clinical Outcome (EPCO) definitions

    Measured: until hospital discharge up to 6 months after surgery

  2. 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

    Measured: until hospital discharge up to 6 months after surgery

  3. Duration of hospitalization (days)

    Duration of hospitalization (days)

    Measured: until hospital discharge up to 6 months after surgery

  4. in-hospital mortality

    in-hospital mortality

    Measured: until hospital discharge up to 6 months after surgery

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

    Length of stay in the intensive care unit (days)

    Measured: until hospital discharge up to 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start4 Nov 2019
  3. Primary completion11 Feb 2022
  4. Study completion17 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156594
Sponsor's protocol ID
PV7061
Acronym
PRESELECT
Status last verified
May 2023
First submitted
5 Nov 2019
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23287892

  • 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.

    PubMed 25058504

  • 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.

    PubMed 28182564

  • 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.

    PubMed 30070222

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, Obstructive and Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pulmonary complications (PPC) (time frame: until hospital discharge up to 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04156594, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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