NCT06916598

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

Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications- an International Delphi Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Pulmonary Complications

Interventions

Type	Name	Description
OTHER	Delphi study	This Delphi study involves multiple iterative rounds until a stable consensus or dissensus is reached on all the statements.
OTHER	Structured Interview	Structured interviews will be conducted by members of the steering committee and an independent qualitative research expert. A pilot-tested case vignette along with a Likert scale-based questionnaire, will be employed to gather insights regarding the impact and severity of PPCs. The impact of the individual components of PPCs will be evaluated on a 7-point Global Rate of Change (GRC) scale (from "very much worse" to very much better") to calculate the minimal clinical important difference. Patient care representatives will be engaged in anonymous voting on the questionnaire. PPCs' rankings and key themes synthesised from the interviews will be shared with the panel in the second Delphi round, facilitating the integration of patient perspectives into the consensus process.

Timeline

• Start date: 2025-09-08
• Primary completion: 2025-12-30
• Completion: 2026-02-28
• First posted: 2025-04-08
• Last updated: 2025-09-18

Locations

1 site across 1 country: United Kingdom