Clinical trial NCT06649734: Consensus Statements on Airway Clearance Interventions in Intubated Critically Ill Patients--Protocol for a Delphi Study
Official title: Consensus Statements on Airway Clearance Interventions in Intubated Critically Ill Patients--Protocol for a Delphi Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critically Ill
Ventilation Therapy; Complications
Mucus Retention
Airway Clearance Impairment
Keywords: Airway Clearance Techniques
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: The Royal Wolverhampton Hospitals NHS Trust
First posted: 2024-10-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Consensus use of airway clearance intervention Humidification
timeFrame: Time Frame: 3-6 months
measure: Consensus use of airway clearance intervention Inhaled Therapy
timeFrame: Time Frame: 3-6 months
measure: Consensus use of airway clearance intervention Endotracheal Suctioning
timeFrame: Time Frame: 3-6 months
measure: Consensus use of airway clearance intervention Mucus Mobilisation techniques
timeFrame: Time Frame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC
name: Frederique Paulus, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: