Video Assisted System for Nasogastric Tube Placement

Not Applicable

Completed

• Conditions: Enteral Nutrition
• Interventions: Device: NCKU-NG system

• Registration Number: NCT05486286
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

A live-video system (NCKU-NG system) was developed to assist in the placement of an enteral feeding tube. This system consists of a camera and light source that can be inserted into the commercial NG tube to view live video during feeding tube placement. Manual air insufflation can be used to aid feeding tube placement and improve visualization of anatomic landmarks. After the procedure, an abdominal X-ray is done to confirm the position of the feeding tube.

Detailed Description

This study used 15 Fr feeding tubes with an outer diameter of 4.5 mm and an inner diameter of 3.5 mm (Freka®, Bad Homburg, Germany). Patients were advised to maintain nothing by mouth (NPO) for at least four hours before the placement. An insufflation device (Olympus, Tokyo, Japan) was utilized whenever necessary to facilitate feeding tube placement or confirm its position. In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach. After successful insertion, all feeding tubes were securely fixed with tape on the nose. The position of NG tube was reconfirmed by traditional auscultation. Chest X-ray imaging was performed for every patient after the NG tube placement to verify the positioning of the tube by the primary care physician. Time to visual confirmation of stomach position, for completing tube placement with/without air insufflation were recorded. Numbers of attempts, vocal cord/trachea visualization and air insufflation were also recorded. A study assistant monitored the patient's condition for the subsequent seven days, recording any observed complications or adverse events.

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-01
• Study Start: 2022-08-02
• Study First Posted: 2022-08-03
• Primary Completion: 2023-05-03
• Study Completion: 2023-05-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-23
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients (>20 y/o) requiring enteral feeding and/or medication with an expected duration longer than 48 hours were eligible for inclusion.

Exclusion Criteria

• Patients can't receive an X-ray after the procedure to confirm tube position (e.g. pregnancy)
• Patients with hemodynamic instability (defined as mean arterial pressure <65 mmHg)
• Patients with a history of basal skull fracture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
video assisted NG placement	NCKU-NG system	This is a single-arm study. A live-video system (NCKU-NG system) was developed to assist in the placement of enteral feeding tubes.

Primary Outcome Measures

Name	Time	Method
The successful rate (percent) of gastric placement of feeding tubes	up to 24 hours after chest X-ray	The successful rate (percent) of gastric placement of feeding tubes using the video-assistance system (NCKU-NG system), was assessed by X-ray.

Secondary Outcome Measures

Name	Time	Method
opearator evaluation (Liker scale)	immediately after procedure	The operator will evaluate the 1) feasibility of video assistance placement, 2) imaging clearance, 3) whether is it easy to remove the camera probe after reaching the stomach, 4) whether is it easy to confirm the gastric position. All the evaluation is cored on a Liker scale (1-5, whether higher scores mean a better outcome)

Trial Locations

Locations (1)

Chuang Chiao-Hsiung; 🇨🇳 Tainan, Taiwan