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Establishing Safe Gastric Tube Placement in Children Using LED Light

Establishing Safe Gastric Tube Placement in Children Using the Tumguide System: An LED Light-Based Method for Gastric Tube Tip Verification. - Establishing Safe Gastric Tube Placement in Children Using the Tumguide System: An LED Light-Based Method for Gastric Tube Tip Verification.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055947
Enrollment
100
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospitalized children who require a gastric tube

Interventions

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 pos

Sponsors

International University of Health and welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactHironori Shimozawa

International University of Health and welfare Hospital Pediatrcis

shimo1019@iuhw.ac.jp0287-37-2221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026