Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062718) titled 'Cuff-Leak Test Results in Patients Requiring Prolonged Sedation After General Anesthesia: A Prospective Observational Study' on Aug. 29.
Study Type:
Observational
Primary Sponsor:
Institute - Chiba University Hospital
Condition:
Condition - Congenital disorders in children causing facial hypoplasia, cervical myelopathy in adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To observe changes in the cuff-leak test results over time in the intensive care unit until extubation in patients requiring prolonged sedation following surgery under general anesthesia
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligible participants are those who meet either criterion 1) or 2) below.
1) Patients under 18 years of age who undergo facial bone reconstruction surgery under general anesthesia at this facility and are placed on intubated mechanical ventilation in the intensive care unit postoperatively; for those under 16 years of age, the study must be explained to the participant using an assent form to confirm their willingness to participate, and the study must also be explained to the legal guardian using a consent form to obtain written consent; For patients aged 16 years or older but under 18 years, those for whom both the research subject and the surrogate have been informed using a research consent form and written consent has been obtained;
2) Patients aged 18 years or older who undergo cervical anterior fusion under general anesthesia at this facility and are placed on intubated mechanical ventilation in the intensive care unit postoperatively, provided that, after receiving a thorough explanation regarding participation in this study, written consent has been obtained from the patient based on their own free will and full understanding.
Key exclusion criteria - 1) Cases where consent was not obtained
2) Cases following tracheostomy
3) Other cases deemed inappropriate by the researchers
Target Size - 15
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 17 Day
Date of IRB - 2026 Year 08 Month 21 Day
Anticipated trial start date - 2026 Year 08 Month 28 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071812
Disclaimer: Curated by HT Syndication.
