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Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications (PrECiSIOn)

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Invitation-only

Conditions

Postoperative Pulmonary Complications

Treatments

Other: Structured Interview
Other: Delphi study

Study type

Observational

Funder types

Other

Identifiers

NCT06916598
PrECiSIOn

Details and patient eligibility

About

An international team of experts is working on a project called PrECiSIOn to develop a clear, consistent definition of PPCs. The goals of this study are to:

  • Define postoperative pulmonary complications in a way that makes sense for patients, families, and healthcare providers.
  • Rank complications by severity so doctors can focus on the most serious ones first.
  • Decide how and when to monitor patients after surgery to catch problems early.

Full description

Postoperative pulmonary complications (PPCs) are associated with prolonged hospital stays, increased mortality, and significant clinical and economic burdens. Despite their importance, the definition of PPCs varies across studies, leading to inconsistencies in reported incidence rates and research outcomes. Existing definitions, such as the EPCO criteria, have been developed based on expert opinion but lack systematic consensus-building methods.

To address these limitations, the StEP collaboration conducted a systematic review and Delphi process to refine PPC classifications. However, challenges remain, including the lack of universal definitions, hierarchical ranking of complications, and representation from diverse healthcare settings. Composite outcome measures improve statistical power but may obscure differences in severity and clinical significance among PPC subtypes.

The PrECiSIOn Delphi initiative aims to develop an expert consensus on defining PPCs, grading their severity, and determining standardized monitoring methods. The goal is to create a valid, reliable, and universally accepted patient-centered definition of PPCs that enhances comparability across studies and informs clinical decision-making.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Panellists will be identified based on either of the following criteria

  • At least 10 years of clinical experience as a staff member in Anesthesiology, Surgery or Intensive Care Medicine with involvement in care of patients with postoperative complications
  • Author of at least three publications (observational studies or randomised controlled trials) using postoperative pulmonary complications as a primary or secondary outcome For patients and public involvement Individuals who have either personally experienced PPCs following surgery within the last 5 years or, primary caregivers of such patients will be recruited as patient care representatives. Proficiency in English is required. To mitigate potential bias, patient care representatives mustn't maintain a professional or advisory relationship with the steering committee or panellists.

Exclusion Criteria

- None

Trial design

40 participants in 2 patient groups

Delphi Panellists
Description:
An international panel of 35-40 panellists from Anesthesiology, Surgery or Intensive Care Medicine and including patient representatives, will be invited to this Delphi study. A concerted effort will be made to include panellists from low- and middle-income countries and both sexes.
Treatment:
Other: Delphi study
Patient and Public involvement
Description:
Individuals who have either personally experienced PPCs following surgery within the last 5 years or, primary caregivers of such patients will be recruited as patient care representatives.
Treatment:
Other: Structured Interview

Trial contacts and locations

1

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Central trial contact

Prashant Nasa, MD; Sabrine Hemmes, PhD

Data sourced from clinicaltrials.gov

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