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临床试验/NCT07638540
NCT07638540Enrolling By Invitation不适用

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

Al Adan Hospital Kuwait1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1

研究概览

简要总结

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.

详细描述

Introduction:

Optimal patient-ventilator interaction (PVI) is a state of harmony in which ventilatory support is aligned with the patient's neural respiratory drive and breathing pattern, thereby achieving the core goals of mechanical ventilation, including comfort, safety, and timely liberation from the ventilator. Disruption of this harmony results in abnormal PVI patterns, which have been associated with increased work of breathing (WOB), a higher risk of ventilator-induced lung injury (VILI), greater requirement for sedation and neuromuscular blockade, and prolonged duration of mechanical ventilation and intensive care unit (ICU) stay.

Achieving and maintaining optimal PVI requires clinicians to be familiar with its terminology, understand the underlying physiological mechanisms, and recognise, interpret, prevent, and manage abnormal interactions at the bedside. However, PVI terminology remains highly inconsistent. 'Early triggering', 'reverse triggering', and 'neural or ventilator-induced entrainment', are often used interchangeably, while 'double triggering' and 'double cycling' are inconsistently defined and applied. Descriptors, including 'starvation', 'flow mismatch', and 'under-assistance' are variably applied, and terms including 'missed efforts', 'ineffective triggering', 'ineffective efforts', and 'failed trigger' are frequently used to describe the same abnormality. In parallel, broader labels such as dyssynchrony, asynchrony, and PVI patterns coexist without a standardised conceptual hierarchy. This inconsistency reflects a fundamental lack of consensus on how PVI phenomena should be defined and classified.

This lack of standardisation creates confusion and hinders accurate recognition, education, and communication, limits comparability in reporting across studies, and impedes the development of automated detection systems. Although recent initiatives have moved toward greater standardisation, adoption remains incomplete and legacy terminology continues to be widely used.

To address these challenges, we plan an international Delphi consensus, The INTERACT (International Consensus on Patient-Ventilator Interaction Terminology, Classification, Diagnostic Recognition and Reporting) study, to develop a standardised framework for PVI. Specifically, we aim to harmonise terminology, establish a clear and clinically meaningful classification of PVI patterns, define the key diagnostic features and minimal monitoring requirements for their recognition, and propose standardised reporting recommendations for both research and clinical practice. By building expert consensus across disciplines and regions, this initiative seeks to create a shared and practical foundation to improve communication, education, research comparability, and ultimately patient care.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Modified Delphi consensus survey (Other)

研究者

发起方
Al Adan Hospital Kuwait
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Ahmed Said Elmasry, MD, MSc, EDIC

Principal Investigator

Al Adan Hospital Kuwait

研究点 (1)

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