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临床试验/NCT06649734
NCT06649734已完成不适用

Consensus Statements on Airway Clearance Interventions in Intubated Critically Ill Patients--Protocol for a Delphi Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Consensus use of airway clearance intervention Humidification

研究概览

简要总结

Intubated critically ill patients are susceptible to secretion accumulation because of compromised airway clearance. Various airway clearance interventions are employed to prevent complication(s) arising from mucus retention. Available guidelines are largely based on clinical expertise and low-level evidence, with no international consensus on their use. This Delphi study aims to collect global opinions on the usefulness of these various airway clearance interventions. Statements are grouped into two distinct parts: (1) Humidification and Nebulization, and (2) Suctioning and Secretion mobilization techniques.

详细描述

Introduction Intubated critically ill patients are susceptible to secretion accumulation because of compromised airway clearance. Various airway clearance interventions are employed to prevent complication arising from mucus retention. This Delphi study aims to collect global opinions on the usefulness of these various airway clearance interventions. The diverse expertise of the panel will provide valuable insights for refining airway care for intubated critically ill patients, eventually improving outcomes.

Methods The steering committee, comprising of 10 healthcare professionals working in intensive care including two Delphi methodologists, performed a focused literature search on airway clearance methods and drafted statements. Statements are grouped into two distinct parts: (1) Humidification and Nebulization, and (2) Suctioning and Secretion mobilization techniques. For each Delphi part a diverse panel of 35-40 experts will be selected, with concerted effort to involve experts from various medical specialties involved in airway clearance methods inclusive of, but not limited to ICU nurses, respiratory therapists, physiotherapists, intensive care physicians. The identity of these experts will stay anonymized from each other until the end of the Delphi process. Multiple choice questions (MCQs) or 7-point Likert-scale statements will be used in the iterative Delphi rounds to reach consensus on various airway clearance interventions. Comments and feedback from experts will be collected during each Delphi round. Anonymized survey report and comments will be shared with other experts along with link for the consecutive survey. The Delphi rounds will be continued until a stable agreement or disagreement is achieved for all statements. The steering committee will not participate in the voting process during Delphi rounds.

Analysis Consensus will be deemed achieved when a choice in MCQs or a Likert-scale statement achieves ≥ 75% agreement or disagreement. Starting from the second round of the Delphi process, stability will be assessed using non-parametric χ2 tests or Kruskal-Wallis tests. Stability will be defined by a P-value of ≥ 0.05.

Ethics and dissemination The study will be conducted in strict accordance with the principles of the Declaration of Helsinki and reported following ACCORD guidelines. An ethical approval waiver has been granted, due to the nature of the research. Participation in the study is voluntary, and completing and returning the survey will be considered as explicit consent to take part in the study. The study results will be published in a peer-reviewed journal. Patients' representatives will be involved to ensure their perspectives are considered throughout the research process.

研究设计

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

入排标准

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

入选标准

  • Healthcare professionals will be selected as panelists based on the following criteria:
  • Inclusion criteria:
  • at least 5 years of clinical experience, with care for invasively ventilated patients (teaching and non-teaching); and
  • participation in development of a guideline or authorship of at least one peer reviewed published paper in airway care for invasive ventilated patients; and
  • not more than 70% of the panelists from each sex; and from each of high and low- and middle-income countries.

排除标准

  • Purposive sampling will be utilized to recruit panelists by reviewing recent publications in the field of airway care for invasive ventilated patients. Selection of panelists will be guided by predefined criteria, with deliberate efforts to ensure a balance in gender and geographical representation.

研究组 & 干预措施

Expert Panel

An international expert panel of at least 35 to 40 healthcare professionals representing ICU-nurses, respiratory therapists (or comparable version, based on local implementation), physiotherapists, ICU-physicians and pulmonologists with expertise in the field of invasively ventilated ICU-patients.

干预措施: Delphi Study (Other)

结局指标

主要结局

Consensus use of airway clearance intervention Humidification

时间窗: Time Frame: 3-6 months

Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on Humidification in invasively ventilated Intensive Care patients.

Consensus use of airway clearance intervention Inhaled Therapy

时间窗: Time Frame: 3-6 months

Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on Inhaled Therapy in invasively ventilated Intensive Care patients.

Consensus use of airway clearance intervention Endotracheal Suctioning

时间窗: Time Frame: 3-6 months

Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on Endotracheal Suctioning in invasively ventilated Intensive Care patients.

Consensus use of airway clearance intervention Mucus Mobilisation techniques

时间窗: Time Frame: 3-6 months

Diverse group of panelist across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on Mucus Mobilisation techniques in invasively ventilated Intensive Care patients.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Marcus J. Schultz

professor dr.

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

研究点 (1)

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