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Enrolling by Invitation

NCT Number: NCT06916598

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New Cross Hospital

Wolverhampton, WV100QP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delphi study

Other

This Delphi study involves multiple iterative rounds until a stable consensus or dissensus is reached on all the statements.

Structured Interview

Other

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.

Primary outcomes

  1. Generate consensus on the postoperative pulmonary complications construct

    Time frame: 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 outcomes

  1. Generate consensus on the postoperative pulmonary complications definition and components

    Time frame: 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

  2. Generate consensus on the on the timeframe of monitoring for postoperative pulmonary complications

    Time frame: 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

  3. Generate consensus on the methods of monitoring of postoperative pulmonary complications

    Time frame: 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.

  4. Generate consensus on weightage grade of individual postoperative pulmonary complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust
  • University of Wolverhampton

Registry information

Official study title

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

Acronym: PrECiSIOn

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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