Mechanical Insufflation-Exsufflation in Critically Ill Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedipol University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

experts on MI-E

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Delphi Questionnaire

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experts1 intervention

Trial outcomes

Primary outcomes

1

Primary Consensus Output

Number (or Proportion) of clinical practice statements achieving international expert consensus on the use of Mechanical Insufflation-Exsufflation (MI-E) in critically ill patients.

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medipol University

Lead sponsor

International Association of Non Invasive Ventilation

Collaborator

International Academy of Non Invasive Ventilation

Collaborator

International College of Experts of Non Invasive Ventilation

Collaborator