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Postoperative Pulmonary ComplicationsPrECiSIOnNCT06916598

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

An observational study of Postoperative Pulmonary Complications, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Pulmonary Complications
What is being tested?
Delphi study and Structured Interview
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
8 Sep 2025to 28 Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • New Cross Hospital

    Wolverhampton, Wolverhampton, WV100QP

Other trials in United Kingdom

About this study

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

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.
Read the 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.

Being tested
Delphi study, Structured Interview
Keywords
postoperative pulmonary complications, postoperative complications, postoperative pulmonary atelectasis, postoperative pulmonary care, outcomes assessment, Delphi study
Medical subject headings
Postoperative Complications, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delphi studyOther

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

  • Structured InterviewOther

    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.

Study groups in NCT06916598
Study groupRoleWhat they receive
Delphi PanellistsAn 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.
Receives: Other: Delphi study
Patient and Public involvementIndividuals 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.
Receives: Other: Structured Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-6 months

Secondary outcomes (4)
  1. Generate consensus on the postoperative pulmonary complications definition and components

    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

    Measured: 3-6 months

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

    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

    Measured: 3-6 months

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

    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.

    Measured: 3-6 months

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

    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.

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start8 Sep 2025
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06916598
Sponsor's protocol ID
PrECiSIOn
Acronym
PrECiSIOn
Status last verified
Apr 2025
First submitted
1 Apr 2025
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The IPD is available to investigators and can be shared with appropriate requests.

Publications

  • 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.

    PubMed 27106961
  • 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.

    PubMed 37448627
  • 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.

    PubMed 29661384
  • 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.

    PubMed 25058504
  • 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.

    PubMed 37303413
  • 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.

    PubMed 21572323
  • 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.

    PubMed 26020123
  • 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.

    PubMed 37730455
  • 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.

    PubMed 27829093
  • 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.

    PubMed 40829816

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pulmonary Complications, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Generate consensus on the postoperative pulmonary complications construct (time frame: 3-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06916598, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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