跳至主要内容
临床试验/NCT07420946
NCT07420946招募中不适用

Mechanical Insufflation-Exsufflation in Critically Ill Patients: An International DELphi Consensus (DELMI-E)

Medipol University4 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2026年6月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
4
主要终点
Primary Consensus Output

研究概览

简要总结

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

详细描述

Background: Mechanical insufflation-exsufflation (MI-E) functions as a noninvasive method which clears airways through its ability to enhance cough performance by delivering positive pressure to initiate airflow and then rapidly applies negative pressure for exhalation. MI-E enables bronchial secretions to be moved and eliminated through its ability to produce high expiratory flows while decreasing the chances of secretions being retained in the lungs.

MI-E is well established in patients with neuromuscular diseases and chronic respiratory disorders, in which weak cough and airway clearance dysfunction are the main contributors to respiratory morbidity. Nevertheless, the use of this technique in critically ill patients, particularly those admitted to the intensive care unit (ICU), is still diverse and insufficiently standardized. Invasive and non invasive ventilation, sedation, impaired consciousness, artificial airways, and respiratory muscle dysfunction substantially alter cough physiology in ICU patients, increasing risk of secretion retention, atelectasis, extubation failure, and reintubation.

Research on MI-E applications for ICU patients has become more popular but current clinical practices show different standards for selecting patients and determining treatment times and establishing device settings and conducting safety checks and managing restricted treatment conditions and integrating MI-E use with other ventilation modalities. A few studies available are restricted by small sample sizes, mixed populations, and varying outcome definitions, thus no clear recommendations can be made. Concerns about safety, such as the risk of barotrauma and damage to the airway, changes in clinical practice, and the requirement for staff skills and training are some of the factors that cause uncertainty and inconsistency in the use of MI-E in critically ill patients.

In situations where there are few high-quality randomized trials giving the evidence, expert consensus is now generally considered to be a proper and effective methodology to determine clinical best practice. The Delphi method with the addition of fuzzy logic is a way of systematically collecting and combining the experts' opinions, and it also counteracts the influence of the strongest participants and allows the identification of the recommendations that should be given priority, both from the point of view of their clinical relevance and of their feasibility.

Therefore, it is necessary to carry out a global, multidisciplinary Delphi consensus study in order to identify best practices and agree on consensus, based guidelines for implementing MI-E therapy in critical care patients.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Healthcare professionals with documented clinical experience in critical care medicine, pulmonology, anesthesiology, respiratory therapy, or physiotherapy with involvement in airway clearance strategies.
  • Demonstrated experience or recognized expertise in the clinical use of MI-E, either in critically ill patients or in patients with complex respiratory conditions.
  • A minimum of 5 years of clinical experience in their respective field, or a proven academic or clinical contribution related to MI-E.
  • Willingness to participate in multiple Delphi rounds and to provide informed consent.
  • Ability to complete the questionnaires in English.

排除标准

  • Lack of direct clinical or academic experience related to MI-E or airway clearance techniques.
  • Inability or unwillingness to provide informed consent.
  • Failure to complete the first Delphi round after formal invitation and consent.
  • Withdrawal of consent at any stage of the Delphi process.

研究组 & 干预措施

Experts

Healthcare professionals with documented clinical experience in critical care medicine, pulmonology, anesthesiology, respiratory therapy, or physiotherapy with involvement in airway clearance strategies.

干预措施: Delphi Questionnaire (Other)

结局指标

主要结局

Primary Consensus Output

时间窗: through study completion, an average of 1 year

Number (or Proportion) of clinical practice statements achieving international expert consensus on the use of Mechanical Insufflation-Exsufflation (MI-E) in critically ill patients.

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berkan Basançelebi

Principal Investigator

Medipol University

研究点 (4)

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