Clinical Trial: Comparison of Perioperative Complications Between Cuffed and Cuffless Tubes in Pediatric Nasotracheal Intubation: A Randomized Controlled Trial (Japan)

Tokyo, Feb. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060558) titled 'A Study on the Incidence of Perioperative Complications Associated with the Presence or Absence of a Cuff in Endotracheal Tubes During Pediatric Nasal Intubation' on Feb. 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Kyushu Dental University

Condition: Condition - Dental phobia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Traditionally, cuffless endotracheal tubes were frequently chosen for airway management during general anesthesia in pediatric patients. In recent years, cuffed endotracheal tubes have become more commonly used during orotracheal intubation. This has been shown to reduce the need for tube exchange and lower the reintubation rate. For non-cooperative pediatric patients undergoing general anesthesia, nasopharyngeal intubation is often chosen. However, selecting the appropriate tube size is frequently challenging due to the difference in diameter between the trachea and the nasal cavity. While cuffed tubes reduce reintubation rates, they can also cause damage to the nasal mucosa during passage through the nasal cavity or be obstructed by the cuff itself. Consequently, there is currently no significant difference in the usage rates of the two types of tubes, and the choice is left to the discretion of the anesthesiologist. This study aimed to determine the optimal endotracheal tube for pediatric nasotracheal intubation by comparing nasotracheal intubation using cuffless tubes versus cuffed tubes. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Nasal endotracheal intubation with a cuffed endotracheal tube Interventions/Control_2 - Nasal endotracheal intubation without a cuffed endotracheal tube

Eligibility: Age-lower limit - 3 years-old = Gender - Male and Female Key inclusion criteria - Forty children aged 3 to 12 years with no systemic diseases who were non-cooperative for treatment, scheduled for dental treatment under general anesthesia, and for whom informed consent was obtained from their guardians. Key exclusion criteria - Patients with systemic disease Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2023 Year 07 Month 01 Day Date of IRB - 2023 Year 07 Month 12 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 07 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069274

Disclaimer: Curated by HT Syndication.