UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055947 |
|---|---|
| Receipt number | R000063917 |
| Scientific Title | Establishing Safe Gastric Tube Placement in Children Using the Tumguide System: An LED Light-Based Method for Gastric Tube Tip Verification. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/07/18 15:03:54 |
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Basic information
Public title
Establishing Safe Gastric Tube Placement in Children Using LED Light
Acronym
Establishing Safe Gastric Tube Placement in Children Using LED Light
Scientific Title
Establishing Safe Gastric Tube Placement in Children Using the Tumguide System: An LED Light-Based Method for Gastric Tube Tip Verification.
Scientific Title:Acronym
Establishing Safe Gastric Tube Placement in Children Using the Tumguide System: An LED Light-Based Method for Gastric Tube Tip Verification.
Region
| Japan |
Condition
Condition
Hospitalized children who require a gastric tube
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the safety and accuracy of inserting and placing nasogastric or orogastric tubes using the Tumguide system, an LED light-based method for gastric tube tip verification, in pediatric patients, including neonates and children requiring medical assistance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of Success Rate and Accuracy of Gastric Tube Placement: Radiographs are taken after placing the gastric tube using the Tumguide system to determine if it was successfully positioned in the stomach beyond the cardia. The final insertion length of the gastric tube is measured from the radiographs and compared with the length determined by the Tumguide system and calculated based on the patient's physique.
Key secondary outcomes
Evaluate the occurrence of adverse events related to gastric tube placement, including incorrect insertion into the trachea, gastrointestinal perforation, vomiting, and severe bradycardia associated with vagus nerve reflex. Additionally, assess the burden reduction achieved through gastric tube placement in children who require medical assistance. Analyze the risk factors contributing to failed gastric tube placement.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Medical personnel insert a nasogastric or orogastric tube into a pediatric patient using the Tumguide system, an LED-based method for gastric tube tip verification, ensuring the tip of the tube is positioned appropriately within the stomach.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Neonates, infants, and children requiring the placement of a nasogastric or orogastric tube who are admitted to the research facility.
2. Consent to participate in the research is obtained based on the free will of the surrogate or the individual after a sufficient explanation has been provided.
Key exclusion criteria
1. Complications requiring surgery along the route from the nasal cavity or oral cavity to the stomach (e.g., esophageal atresia, hiatal hernia, tracheoesophageal fistula)
2. Individuals deemed inappropriate as research subjects by the research director or co-researcher.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Shimozawa |
Organization
International University of Health and welfare Hospital
Division name
Pediatrcis
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara-shi, Tochigi
TEL
0287-37-2221
shimo1019@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Shimozawa |
Organization
International University of Health and welfare Hospital
Division name
Pediatrcis
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara-shi, Tochigi
TEL
0287-37-2221
Homepage URL
shimo1019@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tochigi Regional Ethics Review Board of International University of Health and Welfare
Address
2600-1 Kitakanemaru, Otawara-shi, Tochigi
Tel
0287-39-3060
s-rinri@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国際医療福祉大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
Results
The overall success rate of intragastric tube placement was 98% (52/53), and the placement accuracy was 68% (36/53).
Placement accuracy was significantly higher in Phase 2 (83% vs. 17%, p < 0.001). Tumguide demonstrated a significantly smaller error than NEMU and WBF. Additionally, the Tumguide method maintained consistently small placement errors regardless of body weight in Phase 2, in contrast to NEMU and WBF, whose placement errors increased with higher body weight.
Results date posted
| 2025 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median gestational age and birth weight were 37.4 weeks (interquartile range [IQR]: 34.3, 39.4), and 2,577 g (IQR: 1,998, 2,965), respectively. The median postnatal age at the time of the procedure was 0 days (IQR: 0, 2).
Participant flow
From Nov 1, 2024, to June 30, 2025, the Tumguide system was utilized in 57 procedures involving 46 patients. These included 53 procedures in 44 neonates, one in an eight-month-old infant, and three in a 15-month-old toddler. As most procedures were performed in neonates, only neonatal cases were analyzed. Among these, 12 procedures were conducted during Phase 1 and 41 during Phase 2.
Adverse events
No adverse events such as airway misplacement or respiratory deterioration were observed.
Outcome measures
The primary outcomes were the success rate of intragastric tube placement and the placement accuracy. Successful placement was defined as having the side hole of the feeding tube located distal to the gastroesophageal junction. Placement accuracy was defined as the proportion of cases not requiring post-placement adjustment. The term placement accuracy used in this study corresponds closely to correct intragastric tube placement as reported in previous studies, both referring to successful positioning of the tube tip beyond the gastroesophageal junction without exerting pressure on the gastric wall, as confirmed on radiographs.
Secondary outcomes included placement error, the incidence of adverse events, and factors associated with unsuccessful placement. Placement error was calculated as the insertion length minus the final adjusted length. The insertion length was defined as the initial insertion length determined using the Tumguide method or the estimated insertion lengths determined using the nose-earlobe-mid-umbilicus (NEMU) and weight-based formula (WBF) methods.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063917
