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

NCT ID: NCT06649734

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-09-30

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.

Conditions

Critically Ill; Ventilation Therapy; Complications; Mucus Retention; Airway Clearance Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Delphi Study

Intervention Type: OTHER

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

Interventions

Delphi Study

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Marcus J. Schultz

professor dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederique Paulus, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Central Contacts

Frederique Paulus, prof. dr.

Role: CONTACT

f.paulus@amsterdamumc.nl

+31 20 5669111

Willemke Stilma, phd

Role: CONTACT

w.stilma@hva.nl

Other Identifiers

ACCorDingly

Identifier Type: -

Identifier Source: org_study_id