Video Assisted System for Nasogastric Tube Placement

Enteral Nutrition Clinical Trial

Official title:

Clinical Study of a Real-time Video-assisted System for Nasogastric Tube Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486286
• Other study ID #: B-BR-111-006
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: May 10, 2023

Study information

• Verified date: July 2023
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 10, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Device:
• NCKU-NG system
A live-video system (NCKU-NG system) was developed to assist in the placement of enteral feeding tubes. 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 may 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.

Locations

Country	Name	City	State
Taiwan	Chuang Chiao-Hsiung	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure time needed (minutes)	The time to insertion of NG tube (from the nose insertion till reaching the stomach)	Immediately after procedure
Other	number of patients with visualization of the trachea (n, %)	Evaluate how many patient has trachea miss-insertion under this video-assistance	immediately after procedure.
Primary	The successful rate (percent) of gastric placement of feeding tubes	The successful rate (percent) of gastric placement of feeding tubes using the video-assistance system (NCKU-NG system), was assessed by X-ray.	up to 24 hours after chest X-ray
Secondary	opearator evaluation (Liker scale)	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)	immediately after procedure