Standardising Terminology, Classification, Diagnostic Recognition and Reporting of Patient-ventilator Interactions: Protocol for an International Delphi Consensus Study

NCT07638540 | Enrolling By Invitation

• 1 other identifier: INTERACT Delphi Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-ventilator interaction describes how a mechanically ventilated patient's breathing effort aligns with ventilator support. Terminology and classification of abnormal patient-ventilator interaction remain inconsistent across clinical practice, research, and education. The INTERACT study is an international modified Delphi consensus study that will invite multidisciplinary experts to rate and refine statements on terminology, classification, diagnostic recognition, and reporting standards for patient-ventilator interaction. The study aims to develop an internationally agreed glossary, taxonomy, and minimum reporting dataset to improve communication, education, research comparability, and future automated detection systems.

Conditions

Patient-Ventilator Interaction; Asynchrony, Patient-Ventilator

Keywords

Patient-ventilator interaction; Mechanical ventilation; Delphi technique; Consensus; Terminology; Classification; Ventilator asynchrony; Respiratory monitoring; Waveform analysis; Reporting standards

Outcome Measures

Primary Outcomes (1)

• Consensus on patient-ventilator interaction terminology, classification, diagnostic recognition, and reporting statements

  Consensus will be defined as at least 75% agreement or disagreement on Likert-scale items, or at least 75% selection of a single option for multiple-choice items.

  Through completion of Delphi rounds, anticipated within 12 months

Study Arms (1)

International Delphi panellists

Multidisciplinary international experts in adult invasive mechanical ventilation, respiratory monitoring, waveform analysis, patient-ventilator interaction, and/or Delphi consensus methodology who participate in iterative anonymous Delphi survey rounds.

Other: Modified Delphi consensus survey

Interventions

Modified Delphi consensus survey OTHER

Participants will complete iterative anonymous Delphi survey rounds rating statements on patient-ventilator interaction terminology, classification, diagnostic recognition, and reporting standards. No clinical intervention will be delivered.

International Delphi panellists

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU physicians, anaesthesiologists, respiratory therapists, ICU nurses, researchers, engineers, or Delphi methodology experts with relevant expertise.

You may qualify if:

• At least 10 years of experience managing invasively ventilated adult patients with demonstrated patient-ventilator interaction expertise; or authorship of at least two peer-reviewed publications related to patient-ventilator interaction, asynchrony, waveform analysis, or respiratory monitoring; or participation in at least one regional or international guideline, task force, or consensus process related to mechanical ventilation or patient-ventilator interaction.
• Ability to provide electronic informed consent.
• Ability to participate in iterative Delphi survey rounds.

You may not qualify if:

• Declines or withdraws electronic informed consent.
• Unable to complete Delphi surveys in English.
• Does not meet the predefined expertise criteria.
• Duplicate representation from the same institution if institutional representation limits are exceeded.

Sponsors & Collaborators

• Al Adan Hospital Kuwait: lead

Study Sites (1)

Al Adan Hospital

Al Ahmadi, Kuwait, 50000, Kuwait

Location

Related Publications (11)

• 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 BACKGROUND

• Gattrell WT, Hungin AP, Price A, Winchester CC, Tovey D, Hughes EL, van Zuuren EJ, Goldman K, Logullo P, Matheis R, Harrison N. ACCORD guideline for reporting consensus-based methods in biomedical research and clinical practice: a study protocol. Res Integr Peer Rev. 2022 Jun 7;7(1):3. doi: 10.1186/s41073-022-00122-0.

  PMID: 35672782 BACKGROUND

• Nasa P, Jain R, Juneja D. Understanding Delphi methodology - Part 3: Reporting standards, challenges, and biases. Intensive Crit Care Nurs. 2026 Mar 27;96:104397. doi: 10.1016/j.iccn.2026.104397. Online ahead of print. No abstract available.

  PMID: 41903450 BACKGROUND

• Kyo M, Shimatani T, Hosokawa K, Taito S, Kataoka Y, Ohshimo S, Shime N. Patient-ventilator asynchrony, impact on clinical outcomes and effectiveness of interventions: a systematic review and meta-analysis. J Intensive Care. 2021 Aug 16;9(1):50. doi: 10.1186/s40560-021-00565-5.

  PMID: 34399855 BACKGROUND

• Mirabella L, Cinnella G, Costa R, Cortegiani A, Tullo L, Rauseo M, Conti G, Gregoretti C. Patient-Ventilator Asynchronies: Clinical Implications and Practical Solutions. Respir Care. 2020 Nov;65(11):1751-1766. doi: 10.4187/respcare.07284. Epub 2020 Jul 14.

  PMID: 32665426 BACKGROUND

• Gattrell WT, Logullo P, van Zuuren EJ, Price A, Hughes EL, Blazey P, Winchester CC, Tovey D, Goldman K, Hungin AP, Harrison N. ACCORD (ACcurate COnsensus Reporting Document): A reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLoS Med. 2024 Jan 23;21(1):e1004326. doi: 10.1371/journal.pmed.1004326. eCollection 2024 Jan.

  PMID: 38261576 BACKGROUND

• Chatburn RL, El-Khatib M, Mireles-Cabodevila E. A taxonomy for mechanical ventilation: 10 fundamental maxims. Respir Care. 2014 Nov;59(11):1747-63. doi: 10.4187/respcare.03057. Epub 2014 Aug 12.

  PMID: 25118309 BACKGROUND

• Mireles-Cabodevila E, Siuba MT, Chatburn RL. A Taxonomy for Patient-Ventilator Interactions and a Method to Read Ventilator Waveforms. Respir Care. 2022 Jan;67(1):129-148. doi: 10.4187/respcare.09316. Epub 2021 Sep 1.

  PMID: 34470804 BACKGROUND

• de Haro C, Ochagavia A, Lopez-Aguilar J, Fernandez-Gonzalo S, Navarra-Ventura G, Magrans R, Montanya J, Blanch L; Asynchronies in the Intensive Care Unit (ASYNICU) Group. Patient-ventilator asynchronies during mechanical ventilation: current knowledge and research priorities. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):43. doi: 10.1186/s40635-019-0234-5.

  PMID: 31346799 BACKGROUND

• Silva PL, Scharffenberg M, Rocco PRM. Understanding the mechanisms of ventilator-induced lung injury using animal models. Intensive Care Med Exp. 2023 Nov 27;11(1):82. doi: 10.1186/s40635-023-00569-5.

  PMID: 38010595 BACKGROUND

• Pierson DJ. Patient-ventilator interaction. Respir Care. 2011 Feb;56(2):214-28. doi: 10.4187/respcare.01115.

  PMID: 21333181 BACKGROUND

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed S Elmasry, MD, MSc, EDIC

  Department of Anaesthesia and Intensive Care Medicine, Al Adan Hospital, Ministry of Health, Kuwait.

  PRINCIPAL INVESTIGATOR

• Denise Battaglini, MD, PhD

  Anaesthesia and Intensive Care, IRCCS Ospedale Policlinico San Martino, Genoa, Italy; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy

  STUDY DIRECTOR

• Marcus J Schultz, MD, PhD

  Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand; Nuffield Department of Medicine, University of Oxford, Oxford, UK; Medical University of Vienna, Vienna, Austria

  STUDY CHAIR

• Prashant Nasa, MD, PhD

  Department of Critical Care Medicine and Anaesthesia, The Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton, UK; Cantonal Hospital St. Gallen, HOCH Health Ostschweiz, St. Gallen, Switzerland;

  STUDY DIRECTOR

• Pedja Kovacevic, MD, PhD

  University Clinical Centre of the Republic of Srpska, Medical Intensive Care Unit, Banja Luka, Republic of Srpska, Bosnia and Herzegovina; Faculty of Medicine, University of Banja Luka, Banja Luka, Republic of Srpska, Bosnia and Herzegovina

  STUDY DIRECTOR

• Juliana C Ferreira, MD, PhD

  Department of Pulmonology, Divisao de Pneumologia, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brasil.

  STUDY DIRECTOR

• Patricia R Rocco, MD, PhD

  9-10- Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.

  STUDY DIRECTOR

• Ehab G Daoud, MD, PhD

  Department of Internal Medicine, John A. Burns School of Medicine, University of Hawai'i, Honolulu, HI, USA

  STUDY DIRECTOR

• Annemijn H Jonkman, MD, PhD

  Department of Adult Intensive Care, Erasmus Medical Centre, Rotterdam, The Netherlands

  STUDY DIRECTOR

• Ali A Hssain, MD, PhD

  Medical Intensive Care Unit / ECMO Team, Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar

  STUDY DIRECTOR

• Mohammed A Fakher, MD, PhD

  Critical Care Medicine Department, Faculty of Medicine, Cairo University, Egypt.

  STUDY DIRECTOR

• Francesca Collino

  Department of Surgical Science, University of Turin, Turin, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)