Actively Recruiting

Age: 18Years - 89Years
All Genders
ID07098611

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score (REXs STUDY)

Led by Medipol University · Updated on 2026-05-05

470

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Medipol University

Lead Sponsor

I

International Association of Non Invasive Ventilation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs score’s predictive ability. The total study duration extends until the end of 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are in the weaning process from mechanical ventilation after being connected to invasive mechanical ventilation in the intensive care unit.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Daily screening visits in the ICU while on mechanical ventilation

Monitoring

Duration - Duration of weaning process until extubation

Participants who are undergoing routine care for weaning from invasive mechanical ventilation are observed. Data relevant to readiness for extubation are collected as part of standard clinical assessments.

Daily assessments during ICU stay until extubation

Follow-up

Duration - Up to 72 hours post-extubation

Participants are monitored for up to 72 hours after extubation to assess extubation success and related outcomes.

1 to 3 visits post-extubation within 72 hours

Trial Site Locations

Total: 7 locations

1

University of Magallanes

Punta Arenas, Chile

Actively Recruiting

2

Cairo University

Cairo, Egypt

Actively Recruiting

3

Shahid Beheshti University of Medical Sciences

Tehran, Iran

Actively Recruiting

4

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

Naples, Italy

Actively Recruiting

5

Monaldi-Cotugno Hospital

Naples, Italy

Actively Recruiting

6

Hospital General Universitario Morales Meseguer

Murcia, Spain

Actively Recruiting

7

İstanbul Medipol University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Berkan Basançelebi

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.).

Stephen A McClave, Beth E Taylor, Robert G Martindale...

https://pubmed.ncbi.nlm.nih.gov/26773077

Hemoglobin levels and weaning outcome of mechanical ventilation in difficult-to-wean patients: a retrospective cohort study.

Yi-Chun Lai, Sheng-Yuan Ruan, Chun-Ta Huang...

https://pubmed.ncbi.nlm.nih.gov/24015310

Mechanical power density, spontaneous breathing indexes, and weaning readiness following prolonged mechanical ventilation.

Alessandro Ghiani, Swenja Walcher, Azal Lutfi...

https://pubmed.ncbi.nlm.nih.gov/39788438

Predictive value of the negative inspiratory force index as a predictor of weaning success: a crosssectional study.

Phuong Hoang Vu, Viet Duc Tran, Minh Cuong Duong...

https://pubmed.ncbi.nlm.nih.gov/33423439

Factors Associated With Ventilator Weaning Success and Failure in People With Spinal Cord Injury in an Acute Inpatient Rehabilitation Setting: A Retrospective Study.

Radha Korupolu, Hannah Uhlig-Reche, Emmanuel Chigozie Achilike...

https://pubmed.ncbi.nlm.nih.gov/35521063