Tokyo, March 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061022) titled 'Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat' on March 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Tokushima University Hospital
Condition:
Condition - patients undergoing general anesthesia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to evaluate, in patients undergoing tracheal intubation with a single-lumen tube under general anesthesia, whether pre-intubation warming and spiral deflation of the endotracheal tube reduce the force required for intubation compared with the conventional method.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - In the intervention group, the endotracheal tube will be warmed and then used after spiral deflation of the cuff.
Interventions/Control_2 - In the control group, an endotracheal tube prepared with conventional cuff deflation will be used.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - patients aged 20 years or older with American Society of Anesthesiologists Physical Status class I or II
Key exclusion criteria - patients with American Society of Anesthesiologists Physical Status class III, IV, or V; patients undergoing head and neck surgery; patients with preoperative sore throat or hoarseness; patients with a history of smoking; patients from whom informed consent cannot be obtained; pregnant women; patients with limited mouth opening; patients with anticipated difficult intubation; and patients with cervical spine disease
Target Size - 130
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 23 Day
Anticipated trial start date - 2026 Year 05 Month 20 Day
Last follow-up date - 2028 Year 06 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069831
Disclaimer: Curated by HT Syndication.