Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062852) titled 'Registry for Automated Mechanical VEntilation in Adults in Japan' on Sept. 9.
Study Type:
Observational
Primary Sponsor:
Institute - Jichi Medical University
Condition:
Condition - Critically ill adult patients requiring high-flow nasal oxygen (HFNO), non-invasive ventilation (NIV), or invasive mechanical ventilation (IMV) during their ICU stay.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to assess the safety and performance of Hamilton Medical AG devices, including automated mechanical ventilation software packages, in critically ill adult patients admitted to the ICU, and to provide real-world evidence on their use in routine clinical practice.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Age 18 years or older.
2. Patients who require high-flow nasal oxygen (HFNO), non-invasive ventilation (NIV), or invasive mechanical ventilation (IMV) at any time during their ICU stay.
Key exclusion criteria - 1. Patients expected to be weaned from HFNO or NIV within 2 hours.
2. Patients expected to be weaned or extubated from IMV within 2 hours without requiring HFNO or NIV support.
3. Patients expected to be transferred to a non-participating ICU within 2 hours.
4. Patients expected to die within 2 hours.
5. Patients who refuse collection of clinical data.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 19 Day
Date of IRB - 2026 Year 05 Month 27 Day
Anticipated trial start date - 2026 Year 09 Month 09 Day
Last follow-up date - 2029 Year 09 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071954
Disclaimer: Curated by HT Syndication.
