Delphi consensus to guide mechanical insufflation-exsufflation use in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international Delphi consensus study aimed at developing expert-based, feasible guidelines for the safe and effective use of mechanical insufflation-exsufflation (MI-E) in intensive care. The study will recruit experienced healthcare professionals across critical care, pulmonology, anesthesiology, respiratory therapy, and physiotherapy to complete multiple rounds of questionnaires. The goal is to standardize patient selection, timing, device settings, safety checks, and integration with other ventilation modalities in the ICU. Although MI-E is established for chronic respiratory conditions, its ICU use varies and lacks high-quality evidence to support uniform recommendations. Outcomes will inform best practices and identify gaps for future research.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Berkan Basançelebi — Medipol University
• Study coordinator: Berkan Basançelebi
• Email: berkan.basancelebi@medipol.edu.tr
• Phone: +90 444 8 544

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.