NCT06649734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

November 12, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

October 1, 2024

Last Update Submit

February 18, 2026

Conditions

Keywords

Airway Clearance Techniques

Outcome Measures

Primary Outcomes (4)

  • Consensus use of airway clearance intervention Humidification

    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.

    Time Frame: 3-6 months

  • Consensus use of airway clearance intervention Inhaled Therapy

    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.

    Time Frame: 3-6 months

  • Consensus use of airway clearance intervention Endotracheal Suctioning

    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.

    Time Frame: 3-6 months

  • Consensus use of airway clearance intervention Mucus Mobilisation techniques

    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.

    Time Frame: 3-6 months

Study Arms (1)

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.

Other: Delphi Study

Interventions

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

Expert Panel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Hospital

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederique Paulus, prof. dr.

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor dr.

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 21, 2024

Study Start

November 12, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations