Clinical trial NCT06916598: Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications
Official title: Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications- an International Delphi Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Pulmonary Complications
Keywords: postoperative pulmonary complications
postoperative complications
postoperative pulmonary atelectasis
postoperative pulmonary care
outcomes assessment
Delphi study
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University of Wolverhampton
name: The Royal Wolverhampton Hospitals NHS Trust
First posted: 2025-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Panellists will be identified through purposive sampling from the publications on PPCs and will meet the above-mentioned selection criteria. After confirming their acceptance, the Experts will be engaged in the Delphi process, explaining the objectives, their role, and the methodology. To encourage continuing engagement of the panellists and to help prevent them from dropping out before completion of the entire process, periodic reminders will be sent before and during the Delphi rounds.

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.

Eligibility 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

Exclusion Criteria

- None

Primary outcomes:
measure: Generate consensus on the postoperative pulmonary complications construct
timeFrame: 3-6 months
Secondary outcomes:
measure: Generate consensus on the postoperative pulmonary complications definition and components
timeFrame: 3-6 months
measure: Generate consensus on the on the timeframe of monitoring for postoperative pulmonary complications
timeFrame: 3-6 months
measure: Generate consensus on the methods of monitoring of postoperative pulmonary complications
timeFrame: 3-6 months
measure: Generate consensus on weightage grade of individual postoperative pulmonary complications
timeFrame: 3-6 months
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus Schultz, PhD
role: STUDY_CHAIR
References:
citation: Myles PS, Grocott MP, Boney O, Moonesinghe SR; COMPAC-StEP Group. Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth. 2016 May;116(5):586-9. doi: 10.1093/bja/aew066. No abstract available.
citation: Gottlieb M, Caretta-Weyer H, Chan TM, Humphrey-Murto S. Educator's blueprint: A primer on consensus methods in medical education research. AEM Educ Train. 2023 Jul 11;7(4):e10891. doi: 10.1002/aet2.10891. eCollection 2023 Aug.
citation: Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.
citation: 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.
citation: Lusquinhos J, Tavares M, Abelha F. Postoperative Pulmonary Complications and Perioperative Strategies: A Systematic Review. Cureus. 2023 May 9;15(5):e38786. doi: 10.7759/cureus.38786. eCollection 2023 May.
citation: Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522.
citation: Canet J, Sabate S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
citation: Piccioni F, Langiano N, Bignami E, Guarnieri M, Proto P, D'Andrea R, Mazzoli CA, Riccardi I, Bacuzzi A, Guzzetti L, Rossi I, Scolletta S, Comi D, Benigni A, Pierconti F, Coccia C, Biscari M, Murzilli A, Umari M, Peratoner C, Serra E, Baldinelli F, Accardo R, Diana F, Fasciolo A, Amodio R, Ball L, Greco M, Pelosi P, Della Rocca G; One-Lung Ventilation Investigators Group (Supplementary Appendix S1). One-Lung Ventilation and Postoperative Pulmonary Complications After Major Lung Resection Surgery. A Multicenter Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2023 Dec;37(12):2561-2571. doi: 10.1053/j.jvca.2023.04.029. Epub 2023 Apr 27.
citation: Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.