RecruitingNCT07420946

Mechanical Insufflation-Exsufflation in Critically Ill Patients

Mechanical Insufflation-Exsufflation in Critically Ill Patients: An International DELphi Consensus (DELMI-E)

Sponsor

Medipol University

Enrollment

30 participants

Start Date

Jun 10, 2026

Study Type

OBSERVATIONAL

Conditions

Airway Clearance Critical Illness Critical Care Critical Care, Intensive Care Consensus Mechanical Insufflation-exsufflation Mechanical Insufflation-exsufflation Session ( With Cough Assist)Delphi 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

Inclusion Criteria5

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 Criteria4

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.

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Interventions

OTHERDelphi 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.