IWS Diagnosis Criteria Consensus

NCT07316894 | Recruiting DMC

• 1 other identifier: 10122025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is an International Delphi Consensus on the Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in adult critically ill patients. It involves the anonymous completion of a questionnaire using a 7-point Likert scale.

Conditions

Iatrogenic Withdrawal Syndrome

Keywords

iatrogenicwithdrawalsyndrome; ICU; delphiconsensus

Outcome Measures

Primary Outcomes (1)

• Diagnostic Criteria of IWS

  The diagnostic criteria of IWS will be determined based on the items reaching the consensus

  4 monts

Interventions

ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS. OTHER

This is a new and originally developed questionnaire comprising of 19 questions. Out of 19 questions, 17 use a 7-point Likert scale response, one uses a Yes/No type of answer and one has open answers.

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

Professionals from the following medical specialties are eligible: Intensive Care Medicine, Anesthesiology or Psychiatry. Participants to this Delphi Consensus must have at least 5 years of experience in their field. Academic title or previous research published in the field of Iatrogenic Withdrawal Syndrome are not mandatory.

You may qualify if:

• At least 5 years of experience or training or research in the field of Intensive Care Medicine, Anesthesiology or Psychiatry

You may not qualify if:

• Not a specialist in the fields of Intensive Care Medicine, Anesthesiology or Psychiatry

Sponsors & Collaborators

• ELIAS Emergency University Hospital: lead
• University of Rome Tor Vergata: collaborator
• Boston University: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator

Study Sites (1)

Elias Emergency University Hospital

Bucharest, 011461, Romania

RECRUITING

Related Publications (1)

• Moisa E, Tuculeanu G, Corneci D, Negoita SI, Bilotta F. Iatrogenic withdrawal syndrome in adult intensive care unit: a scoping review. Front Med (Lausanne). 2025 Jul 23;12:1573363. doi: 10.3389/fmed.2025.1573363. eCollection 2025.

  PMID: 40771468 BACKGROUND

MeSH Terms

Interventions

Intensive Care Units; Anesthesia

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services; Anesthesia and Analgesia

Study Officials

• Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC

  Elias Emergency University Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, Bucharest

  PRINCIPAL INVESTIGATOR

• Federico Bilotta, Professor, MD, PhD

  Tor Vergata University of Rome

  STUDY CHAIR

Central Study Contacts

Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC

CONTACT

+40753021128; emanuel.moisa@umfcd.ro

Jamel Ortoleva, Assoc. Prof, MD, FASE

CONTACT

812-272-7078

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, DESAIC, Assistant Professor and Specialist of Anaesthesia and Critical Care Medicine,

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: December 13, 2025
• Primary Completion: March 31, 2026
• Study Completion: May 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

RO (1)