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Mechanical Insufflation-Exsufflation in Critically Ill Patients

Study acronym: DELMI-E
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 1, 2026 → Dec 31, 2026
See other at-risk trials from Medipol University

Record History

  1. Primary completion pushed from Sep 1, 2026 to Dec 31, 2026 Completion pushed from Dec 1, 2026 to Apr 1, 2027 · Eligibility criteria expanded, about 9 words · Study description expanded, about 18 words · 1 more Show 4 more changesShow less
    • Completion pushed from Dec 1, 2026 to Apr 1, 2027
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 18 words
    • Publications: details revised at 18 of 19 entries
  2. Recruitment opened Start date changed from estimate of Mar 1, 2026 to Jun 10, 2026 · Study description expanded, about 7 words · Site details revised at 4 of 4 sites · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Mar 1, 2026 to Jun 10, 2026
    • Study description expanded, about 7 words
    • Site details revised at 4 of 4 sites
    • Publications: details revised at 19 of 19 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07420946
Lead Sponsor Medipol University
Collaborators: International Association of Non Invasive Ventilation, International Academy of Non Invasive Ventilation, International College of Experts of Non Invasive Ventilation
Conditions Airway Clearance, Mechanical Insufflation-exsufflation, Mechanical Insufflation-exsufflation Session ( With Cough Assist), Delphi Study, Consensus, Critical Illness, Critical Care, Critical Care, Intensive Care
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov