A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

NCT07098611 | Recruiting

• 1 other identifier: IRB00010984
• Study Type: observational
• Target: 470
• Locations: 6 countries
• Sites: 7

Brief Summary

Liberation from mechanical ventilation involves three steps: weaning, readiness assessment, and extubation. Readiness is determined using clinical criteria such as improvement of the underlying condition, hemodynamic stability, and adequate respiratory effort. Successful extubation is defined as not requiring invasive support within 48 hours. Due to the complexity of ICU patients, various clinical parameters and multi-component scores have been developed to predict extubation success. This study aims to develop and evaluate a multi-component score, the Readiness for EXtubation score (REXs), to predict extubation readiness in ICU patients under invasive mechanical ventilation.

Conditions

Extubation Failure; Extubation Succeeded; Intensive Care Patients Invasively Ventilated; Ventilator Weaning; Respiration, Artificial; Respiratory Failure; Extubation Readiness; Weaning Invasive Mechanical Ventilation

Keywords

mechanical ventilation; extubation; weaning; readiness; prediction; score

Outcome Measures

Primary Outcomes (1)

• Extubation failure in 48 hours

  Extubation failure within 48 hours is defined as the need for reintubation or resumption of mechanical ventilation within two days after planned extubation, indicating the patient could not sustain spontaneous breathing independently.

  From the beginning of the extubation process until 48 hours after extubation

Secondary Outcomes (6)

• Extubation failure in 72 hours

  From the beginning of the extubation process until 72 hours after extubation

• Extubation failure in 24 hours

  From the time of extubation until 24 hours post-extubation.

• Length of intensive care stay

  From admission to intensive care to discharge

• Length of hospital stay

  From admission to hospital to discharge

• Intensive care mortality

  From admission to intensive care to discharge

Study Arms (1)

Patients undergoing weaning from invasive mechanical ventilation

In patients who are prepared for extubation, predictive readiness will be assessed with REXs.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on mechanical ventilation admitted to the Intensive Care Unit

You may qualify if:

• \- Patients who are in the weaning process from mechanical ventilation after being connected to invasive mechanical ventilation in the intensive care unit.

You may not qualify if:

• Patients without legal guardian consent.
• Tracheostomized patients.
• Patients enrolled in other studies.
• Individuals with diaphragmatic pacers.
• Pregnant patients.

Sponsors & Collaborators

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

Study Sites (7)

University of Magallanes

Punta Arenas, Chile

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

Shahid Beheshti University of Medical Sciences

Tehran, Iran

RECRUITING

A.O.R.N. "Dei Colli" Monaldi Hospital

Naples, Italy

RECRUITING

Monaldi-Cotugno Hospital

Naples, Italy

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Spain

RECRUITING

İstanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: August 1, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

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

Locations

EG (1); IT (2); TU (1); CL (1); ES (1); IR (1)