Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061918) titled 'Feasibility and safety of the Snorkel Technique for pediatric anesthesia induction: a prospective pilot study' on June 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tsuruoka Municipal Shonai Hospital
Condition:
Condition - Pediatric patients undergoing general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the feasibility, acceptability, and safety of the snorkel technique for induction of general anesthesia in children.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Inhalational induction of anesthesia will be performed using a snorkel-type device rather than a conventional face mask.
Eligibility:
Age-lower limit - 7
years-old
=
Gender - Male and Female
Key inclusion criteria - Children aged 7-12 years scheduled for elective surgery under general anesthesia
Key exclusion criteria - American Society of Anesthesiologists physical status III or higher, Patients for whom written informed consent could not be obtained from the patient and/or a parent, Patients with mental retardation, Patients with neuromuscular disorders or a personal or family history of malignant hyperthermia, Patients with a history of upper respiratory tract infection within the past two weeks, Patients with loose teeth, Patients who cannot hold a snorkel or for whom a snorkel does not fit properly
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 03 Day
Date of IRB - 2026 Year 06 Month 03 Day
Anticipated trial start date - 2026 Year 06 Month 23 Day
Last follow-up date - 2027 Year 06 Month 03 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070852
Disclaimer: Curated by HT Syndication.