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Completed

NCT Number: NCT06649734

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Hospital

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • none

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.

Treatment and study plan

Delphi study

Other

A Delphi study will be conducted with several rounds up to stable expert consensus or dissensus

Primary outcomes

  1. Consensus use of airway clearance intervention Humidification

    Time frame: 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.

  2. Consensus use of airway clearance intervention Inhaled Therapy

    Time frame: 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.

  3. Consensus use of airway clearance intervention Endotracheal Suctioning

    Time frame: 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.

  4. Consensus use of airway clearance intervention Mucus Mobilisation techniques

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust

Registry information

Acronym: ACCorDingly

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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