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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486286
Other study ID # B-BR-111-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach.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.

Study Design


Related Conditions & MeSH terms


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
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