Tokyo, May 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061549) titled 'Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial' on May 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Minor surgical conditions, primarily including superficial bladder cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To demonstrate that the use of lung-protective ventilation during general anesthesia reduces upper airway-related complications.
To evaluate the effects of lung-protective ventilation on the upper airway, particularly on glottic patency.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Lung-protective ventilation group (5 mL/kg)
Interventions/Control_2 - Conventional ventilation group (8 mL/kg)
Eligibility:
Age-lower limit - 18
years-old
=18 years at the time of consent.
2)Adult patients scheduled to undergo minor surgical procedures under general anesthesia managed with a supraglottic airway device.
3)Patients who have received a full explanation of the study, have adequately understood it, and have provided written informed consent voluntarily.
Key exclusion criteria - Patients meeting any of the following criteria:
1)Patients whose upper airway is managed with devices other than a supraglottic airway device.
2)Patients who have withdrawn consent and expressed refusal to participate in this study.
3)Patients with severe hepatic dysfunction.
4)Patients in whom succinylcholine is contraindicated.
5)Patients deemed unsuitable for the study by the principal investigator.
Target Size - 80
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 06 Day
Date of IRB - 2026 Year 02 Month 24 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070429
Disclaimer: Curated by HT Syndication.