Tokyo, July 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058595) titled 'Prospective observational study on the relationship between action potentials emitted by the diaphragm during ventilatory management and the possibility of extubation' on July 25.
Study Type:
Observational
Primary Sponsor:
Institute - Nara Medical University
Condition:
Condition - Respiratory failure requiring ventilator management in the intensive care unit
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Continuous evaluation of Edi (Electrical activity of the diaphragm) and its relationship to VFD28 (ventilator free days at 28days)
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. 18 years of age or older
2. Patients who started ventilator management by oral intubation
3. Cases in which muscle relaxants are administered at the start of ventilation
4.Can be managed in Assist/Control Mode
5. Ventilated with Puritan Bennett980/840, SERVO-U Ventilator, Hamilton C6
6.Patients expected to survive more than 24 hours
Key exclusion criteria - 1. patients who were intubated upon ICU admission
2. pregnant women
3. patients whose diaphragmatic function is not expected to recover (e.g., end-stage neuromuscular disease)
4. Artificial respiration for more than 8 hours prior to admission to the ICU
5. patients who have been in the ICU within the past month
6. patients who have undergone invasive positive pressure ventilation for non-surgical reasons within the past month
7. whose Code is DNAR
8. lack of equipment such as Servo series, NAVA Catheter, etc. 8.
9. absence of investigator
10. failure to obtain research consent
11. drug intoxication
12. brain death
Target Size - 80
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 23 Day
Date of IRB - 2025 Year 06 Month 23 Day
Anticipated trial start date - 2025 Year 06 Month 24 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066020
Disclaimer: Curated by HT Syndication.