Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062632) titled 'Study of nasogastric tube placement using a light-guided tube positioning system' on Aug. 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Jichi Medical University
Condition:
Condition - Hospitalized patients requiring nasogastric tube placement, irrespective of underlying disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether the use of a light-guided catheter system during nasogastric tube placement improves procedural operability and may allow omission of radiographic confirmation after tube placement.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In patients clinically requiring nasogastric tube placement, the MET Light-Guided Catheter System is used concomitantly during nasogastric tube insertion and placement. The light-guided catheter is inserted into the nasogastric tube, and the position of the light source is assessed transcutaneously during and after tube placement. After tube placement, abdominal radiography is performed as part of standard clinical care, and the tube-tip position confirmed by radiography is compared with the position identified using the light-guided catheter system. The intervention is performed at each nasogastric tube placement procedure.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 18 years or older who are clinically judged to require nasogastric tube placement and for whom written informed consent is obtained from the patient or an appropriate legally authorized representative.
Key exclusion criteria - Patients for whom informed consent for participation in the study cannot be obtained.
Patients with a cardiac pacemaker.
Patients with an implantable cardioverter-defibrillator (ICD).
Target Size - 880
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2023 Year 10 Month 18 Day
Date of IRB - 2023 Year 10 Month 26 Day
Anticipated trial start date - 2023 Year 10 Month 27 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071692
Disclaimer: Curated by HT Syndication.