Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060787) titled 'Predicting Pediatric Airway Morbidity with Pre-extubation Fiberoptic Laryngoscopy' on Feb. 28.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hyogo Prefectural Amagasaki General Medical Center
Condition:
Condition - post-extubation laryngeal edema
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To assess the predictive performance of pre-extubation laryngeal fiberoptic imaging for post-extubation upper airway obstruction in pediatric patients.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Laryngeal fiberoptic examination will be performed at the time of extubation. Two physicians will independently assess the pre-extubation laryngeal fiberoptic images using recorded videos that have been prepared so that neither patient-identifying information nor the primary outcome can be ascertained. In cases of disagreement, a final judgment will be reached by consensus after discussion.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - 18
years-old
>=
Gender - Male and Female
Key inclusion criteria - 1. Oral or nasal endotracheal intubation (either is acceptable).
2. Aged 18 years or younger.
3. A Microcuff endotracheal tube is in use
4. Written informed consent has been obtained from the patient and/or a legally authorized representative (the patient's parent/guardian).
5. Extubation is planned between 08:30 and 17:00.
(To ensure assessment quality, the procedure will be performed only during daytime hours so that multiple staff members can attend.)
6. The department conference has determined that performing laryngeal fiberoptic examination is appropriate.
Key exclusion criteria - 1. Unplanned extubation (because the examination cannot be performed).
2. The examination is judged to carry a high risk due to underlying conditions or other clinical factors
(including situations in which transnasal insertion is difficult, such as after head and neck surgery).
3. History of allergy to local anesthetics.
Target Size - 116
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 06 Day
Date of IRB - 2026 Year 01 Month 06 Day
Anticipated trial start date - 2026 Year 03 Month 01 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069436
Disclaimer: Curated by HT Syndication.