Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062858) titled 'Impact of the Fentanyl Supply Shortage on 28-Day Ventilator-Free Days -Changes in Analgesia and Sedation Strategies Following the Fentanyl Supply Shortage-' on Sept. 9.

Study Type: Observational

Primary Sponsor: Institute - Tokushima university hospital

Condition: Condition - Critically ill patients requiring mechanical ventilation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this retrospective multicenter study is to evaluate the impact of changes in analgesia and sedation strategies associated with the fentanyl supply shortage on 28-day ventilator-free days among critically ill adult patients receiving invasive mechanical ventilation in the intensive care unit. Using the One ICU database, changes before and after the supply shortage will be compared across institutions and assessed using a difference-in-differences approach. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients aged 18 years or older who were admitted to the ICU at participating institutions between January 1, 2022, and December 31, 2025, received invasive mechanical ventilation, and had the required data available in the One ICU database. Key exclusion criteria - Patients younger than 18 years Patients who did not receive invasive mechanical ventilation during their ICU stay Patients with missing data for the primary outcome or key covariates required for the analysis Duplicate records from the same hospitalization (only the first ICU admission will be included) Target Size - 5000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 03 Day Anticipated trial start date - 2026 Year 09 Month 29 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071310

Disclaimer: Curated by HT Syndication.