Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063301) titled 'A study to predict breathing deterioration after removal of a breathing tube using ventilator measurements and lung ventilation imaging' on Oct. 16.

Study Type: Observational

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Critically ill adults scheduled for liberation from invasive mechanical ventilation and extubation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine, in invasively ventilated adults who successfully complete a spontaneous breathing trial (SBT) and are scheduled for extubation, whether the change in |P0.1| x rapid shallow breathing index (RSBI) from the early to the late phase of the SBT measured by HAMILTON-C6 and the absolute difference between ventral and dorsal ventilation distribution measured by electrical impedance tomography (EIT) 1-5 minutes after SBT initiation are associated with unplanned rescue noninvasive positive-pressure ventilation (NPPV) or reintubation due to respiratory deterioration within 72 hours after extubation, and to explore the predictive value of combining these indices. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adults aged 18 years or older.

Receiving invasive mechanical ventilation for at least 24 hours in the intensive care unit of Yamagata University Hospital.

Completion of a spontaneous breathing trial (SBT) lasting at least 30 minutes according to the institutional standard procedure, with the treating physician determining that the SBT was successful.

Extubation on the same day has been decided by the treating physician and is expected to occur approximately within 2 hours after the study measurements.

The SBT can be performed using a HAMILTON-C6 ventilator with software version 1.2.3 or later, and the required parameters, including P0.1, respiratory rate, and tidal volume, can be recorded.

Written informed consent can be obtained from the participant or a legally acceptable representative.

If a patient has multiple extubation opportunities, only the first eligible extubation will generally be enrolled. Key exclusion criteria - Presence of a tracheostomy or planned tracheostomy after extubation.

A treatment-limitation decision specifying that reintubation will not be performed.

A significant endotracheal tube leak, bronchopleural fistula, flow-sensor malfunction, or another condition that may make HAMILTON-C6 measurements of ventilation or respiratory mechanics inaccurate.

Severe skin lesions at the EIT belt site, chest-wall anatomy, surgical wounds, medical devices, or other conditions preventing appropriate EIT measurement, or any contraindication to the EIT device.

Unstable hemodynamics, uncontrolled arrhythmia, persistent severe hypoxemia, or another condition making the study measurements unsafe.

Planned prophylactic NPPV immediately after extubation is considered mandatory, making it difficult to distinguish prophylactic from rescue NPPV. Routine planned HFNC use alone is not an exclusion criterion.

Current or possible pregnancy.

Any other condition considered unsuitable for study participation by the treating physician or principal investigator. Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 15 Day Date of IRB - 2026 Year 09 Month 28 Day Anticipated trial start date - 2026 Year 11 Month 15 Day Last follow-up date - 2029 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072458

Disclaimer: Curated by HT Syndication.