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Recruiting Observational

Mechanical Insufflation-Exsufflation in Critically Ill Patients

NCT07420946 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-06-10
Last updated
2026-10-07

Condition(s) studied

Airway ClearanceMechanical Insufflation-exsufflationMechanical Insufflation-exsufflation Session ( With Cough Assist)Delphi StudyConsensusCritical IllnessCritical CareCritical Care, Intensive Care

Investigational drug(s) / intervention(s)

Delphi Questionnaire

Delphi Questionnaire: Statements on MI-E topics, rated along their level of appropriateness on a scale from 1 to 5. Multiple rounds are organised to reach consensus on a topic.

Study summary

Mechanical insufflation-exsufflation (MI-E) is an established airway clearance technique for patients with chronic conditions like neuromuscular diseases. However, its use in critically ill ICU patients remains inconsistent and lacks standardized guidelines. Despite growing research, current practices vary widely in patient selection, treatment protocols, and safety management, with limited high-quality evidence to support clear recommendations. To address this gap, an international, multidisciplinary Delphi consensus study is needed to establish expert-based best practices and feasible guidelines for the safe and effective implementation of MI-E in the intensive care setting.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Healthcare professionals with documented clinical experience in critical care medicine, pulmonology, anesthesiology, respiratory therapy, or physiotherapy with involvement in airway clearance strategies. * Demonstrated experience or recognized expertise in the clinical use of MI-E, either in critically ill patients or in patients with complex respiratory conditions. * A minimum of 5 years of clinical experience in their respective field, or a proven academic or clinical contribution related to MI-E. * Willingness to participate in multiple Delphi rounds and to provide informed consent. * Ability to complete the questionnaires in English. Exclusion Criteria: * Lack of direct clinical or academic experience related to MI-E or airway clearance techniques. * Inability or unwillingness to provide informed consent. * Failure to complete the first Delphi round after formal invitation and consent. * Withdrawal of consent at any stage of the Delphi process.

Primary outcome measure(s)

  • Primary Consensus Output — through study completion, an average of 1 year
    Number (or Proportion) of clinical practice statements achieving international expert consensus on the use of Mechanical Insufflation-Exsufflation (MI-E) in critically ill patients.

Trial sites (4)

FacilityCityRegionStatus
Monaldi Hospital A.O.R.N. dei Colli Naples Italy Recruiting
University of Naples Federico II Naples Italy Recruiting
Hospital General Universitario Morales Meseguer Murcia Spain Recruiting
İstanbul Medipol University Istanbul Istanbul Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420946 on ClinicalTrials.gov ↗ ← All trials in Turkey