Video Assisted System for Nasogastric Tube Placement

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05486286

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A live-video system (NCKU-NG system) was developed to assist in the placement of 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 procedure, an abdominal X-ray is done to confirm the position of the feeding tube.

Condition or Disease	Intervention/Treatment	Phase
Enteral Nutrition	Device: NCKU-NG system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: video assisted NG placement

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

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.

Outcome Measures

Primary Outcome Measures

The successful rate (%) of gastric placement of feeding tubes [< 1 day, after taking CXR]
The successful rate (%) of gastric placement of feeding tubes using the video-assistance system (NCKU-NG system), was assessed by X-ray.

Secondary Outcome Measures

Procedure time needed (minutes) [Immediately after procedure]
The time to insertion of NG tube (from the nose insertion till reaching the stomach)
number of patients with visualization of the trachea (n, %) [immediately after procedure.]
Evaluate how many patient has trachea miss-insertion under this video-assistance
opearator evaluation (Liker scale) [immediately after procedure]
Operator will evaluate the 1) feasibility of video assistance placement, 2) imaging clearance, 3) Is it easy to remove camera probe after reaching the stomach, 4) Is it easy to confirm gastric position. All the evaluation is cored in Liker scale (1-5, whether higer scores mean a better outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chiao-Hsiung Chuang, Associate Professor, National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT05486286

Other Study ID Numbers:

B-BR-111-006

First Posted:

Aug 3, 2022

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2022