Mechanical Insufflation-Exsufflation in Critically Ill Patients

NCT07420946 | Not Yet Recruiting

• 1 other identifier: DELMI-E001
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

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

Keywords

mechanical insufflation-exsufflation; Airway clearance; Delphi study; Consensus; Cough assist; MI-E; critical care

Outcome Measures

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.

  through study completion, an average of 1 year

Study Arms (1)

Experts

Healthcare professionals with documented clinical experience in critical care medicine, pulmonology, anesthesiology, respiratory therapy, or physiotherapy with involvement in airway clearance strategies.

Other: Delphi Questionnaire

Interventions

Delphi Questionnaire OTHER

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.

Experts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

experts on MI-E

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead
• International Association of Non Invasive Ventilation: collaborator
• International Academy of Non Invasive Ventilation: collaborator
• International College of Experts of Non Invasive Ventilation: collaborator

Study Sites (4)

Monaldi Hospital A.O.R.N. dei Colli

Naples, Italy

Location

University of Naples Federico II

Naples, Italy

Location

Hospital General Universitario Morales Meseguer

Murcia, Spain

Location

İstanbul Medipol University

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (19)

• Niederberger M, Schifano J, Deckert S, Hirt J, Homberg A, Koberich S, Kuhn R, Rommel A, Sonnberger M; DEWISS network. Delphi studies in social and health sciences-Recommendations for an interdisciplinary standardized reporting (DELPHISTAR). Results of a Delphi study. PLoS One. 2024 Aug 26;19(8):e0304651. doi: 10.1371/journal.pone.0304651. eCollection 2024.

  PMID: 39186713 RESULT

• Ishikawa A, Amagasa M, Shiga T, Tomizawa G, Tatsuta R, Mieno H. The max-min Delphi method and fuzzy Delphi method via fuzzy integration. Fuzzy Sets Syst. 1993;55(3):241-253. doi:10.1016/0165-0114(93)90251-C

  RESULT

• Hsu CC, Sandford BA. The Delphi Technique: Making Sense of Consensus - Practical Assessment, Research & Evaluation. Practical Assessment, Research, and Evaluation. 2007;12(10):1-8.

  RESULT

• Niederberger M, Spranger J. Delphi Technique in Health Sciences: A Map. Front Public Health. 2020 Sep 22;8:457. doi: 10.3389/fpubh.2020.00457. eCollection 2020.

  PMID: 33072683 RESULT

• Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.

  PMID: 28190381 RESULT

• Saitoh Y, Miyazaki M, Arai N, Takahashi Y. Pneumomediastinum while using mechanical insufflation-exsufflation after recovery from riluzole-induced interstitial lung disease. eNeurologicalSci. 2021 Feb 2;22:100326. doi: 10.1016/j.ensci.2021.100326. eCollection 2021 Mar.

  PMID: 33598572 RESULT

• Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6.

  PMID: 36878644 RESULT

• Volpe MS, Guimaraes FS, Morais CC. Airway Clearance Techniques for Mechanically Ventilated Patients: Insights for Optimization. Respir Care. 2020 Aug;65(8):1174-1188. doi: 10.4187/respcare.07904.

  PMID: 32712584 RESULT

• Maggiore SM, Lellouche F, Pigeot J, Taille S, Deye N, Durrmeyer X, Richard JC, Mancebo J, Lemaire F, Brochard L. Prevention of endotracheal suctioning-induced alveolar derecruitment in acute lung injury. Am J Respir Crit Care Med. 2003 May 1;167(9):1215-24. doi: 10.1164/rccm.200203-195OC. Epub 2003 Feb 13.

  PMID: 12615633 RESULT

• Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.

  PMID: 23641924 RESULT

• Swingwood E, Stilma W, Tume L, Cramp F, Paulus F, Schultz M, Scholte Op Reimer W, Rose L. The use of mechanical insufflation-exsufflation in invasively ventilated critically ill adults: a scoping review protocol. Syst Rev. 2020 Dec 8;9(1):287. doi: 10.1186/s13643-020-01547-8.

  PMID: 33292485 RESULT

• Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.

  PMID: 35610033 RESULT

• Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2023 Nov;28(6):923-930. doi: 10.1111/nicc.12858. Epub 2022 Dec 4.

  PMID: 36464804 RESULT

• Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.

  PMID: 11359958 RESULT

• Toussaint M, Boitano LJ, Gathot V, Steens M, Soudon P. Limits of effective cough-augmentation techniques in patients with neuromuscular disease. Respir Care. 2009 Mar;54(3):359-66.

  PMID: 19245730 RESULT

• Sancho J, Servera E, Diaz J, Marin J. Efficacy of mechanical insufflation-exsufflation in medically stable patients with amyotrophic lateral sclerosis. Chest. 2004 Apr;125(4):1400-5. doi: 10.1378/chest.125.4.1400.

  PMID: 15078752 RESULT

• Bach JR. Mechanical insufflation-exsufflation. Comparison of peak expiratory flows with manually assisted and unassisted coughing techniques. Chest. 1993 Nov;104(5):1553-62. doi: 10.1378/chest.104.5.1553.

  PMID: 8222823 RESULT

• Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.

  PMID: 12172066 RESULT

• Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8. doi: 10.1183/09031936.03.00048102.

  PMID: 12662009 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Berkan Basançelebi

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berkan Basançelebi

CONTACT

+90 444 8 544; berkan.basancelebi@medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1); TU (1)