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

NCT06916598 | Enrolling By Invitation

• 1 other identifier: PrECiSIOn
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pulmonary Complications

Keywords

postoperative pulmonary complications; postoperative complications; postoperative pulmonary atelectasis; postoperative pulmonary care; outcomes assessment; Delphi study

Outcome Measures

Primary Outcomes (1)

• Generate consensus on the postoperative pulmonary complications construct

  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.

  3-6 months

Secondary Outcomes (4)

• Generate consensus on the postoperative pulmonary complications definition and components

  3-6 months

• Generate consensus on the on the timeframe of monitoring for postoperative pulmonary complications

  3-6 months

• Generate consensus on the methods of monitoring of postoperative pulmonary complications

  3-6 months

• Generate consensus on weightage grade of individual postoperative pulmonary complications

  3-6 months

Study Arms (2)

Delphi Panellists

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.

Other: Delphi study

Patient 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.

Other: Structured Interview

Interventions

Delphi study OTHER

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

Delphi Panellists

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.

Patient and Public involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To encourage the continued engagement of the panellists and help prevent them from dropping out before completing the full process, at least three personalised email reminders will be sent during each Delphi round, in addition to an effort to establish personal contact. Furthermore, all panellists will be recognised as collaborative authors in the final publication in appreciation of their professional expertise. Should the attrition rate of panellists exceed 20%, a sensitivity analysis will be conducted, considering the plausible worst-case and best-case scenarios, and taking into account the opinions of non-responders.

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• University of Wolverhampton: collaborator
• The Royal Wolverhampton Hospitals NHS Trust: collaborator

Study Sites (1)

New Cross Hospital

Wolverhampton, Wolverhampton, WV100QP, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 27106961 BACKGROUND

• 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.

  PMID: 37448627 BACKGROUND

• 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.

  PMID: 29661384 BACKGROUND

• 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.

  PMID: 25058504 BACKGROUND

• 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.

  PMID: 37303413 BACKGROUND

• 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.

  PMID: 21572323 BACKGROUND

• 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.

  PMID: 26020123 BACKGROUND

• 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.

  PMID: 37730455 BACKGROUND

• 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.

  PMID: 27829093 BACKGROUND

• Nasa P, Yurttas T, Battaglini D, Blot S, Fernandez-Bustamante A, Gama de Abreu M, van Meenen DM, Myatra SN, Serpa Neto A, Oppong R, Paulus F, Renukappa S, Schultz MJ, Slutsky AS, Hemmes SNT; PrECiSIOn-group. Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication-protocol for an international mixed-method consensus study (PrECiSIOn). BMJ Open. 2025 Aug 19;15(8):e103888. doi: 10.1136/bmjopen-2025-103888.

  PMID: 40829816 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcus Schultz, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: September 8, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)