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

Not yet recruiting

• Conditions: Postoperative Pulmonary Complications

• Registration Number: NCT06916598
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-05-30
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

• None

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Generate consensus on the postoperative pulmonary complications construct	3-6 months	A diverse group of panellists worldwide, based on pre-specified qualification criteria, will conduct iterative Delphi rounds to generate consensus on the construct of postoperative pulmonary complications.

Secondary Outcome Measures

Name	Time	Method
Generate consensus on the postoperative pulmonary complications definition and components	3-6 months	A diverse group of panellists worldwide, based on pre-specified qualification criteria, will conduct iterative Delphi rounds to generate consensus on the definition and components of postoperative pulmonary complications
Generate consensus on weightage grade of individual postoperative pulmonary complications	3-6 months	A diverse group of panellists worldwide, based on pre-specified qualification criteria, will conduct iterative Delphi rounds to generate consensus on weightage grade of individual postoperative pulmonary complications.
Generate consensus on the on the timeframe of monitoring for postoperative pulmonary complications	3-6 months	A diverse group of panellists worldwide, based on pre-specified qualification criteria, will conduct iterative Delphi rounds to generate consensus on the timeframe of monitoring for postoperative pulmonary complications
Generate consensus on the methods of monitoring of postoperative pulmonary complications	3-6 months	A diverse group of panellists worldwide, based on pre-specified qualification criteria, will conduct iterative Delphi rounds to generate consensus on the methods of monitoring of postoperative pulmonary complications.