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Completed

NCT Number: NCT05486286

Video Assisted System for Nasogastric Tube Placement

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuang Chiao-Hsiung

Tainan, 704, Taiwan

About this study

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 In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NCKU-NG system

Device

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.

Primary outcomes

  1. The successful rate (percent) of gastric placement of feeding tubes

    Time frame: 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 outcomes

  1. opearator evaluation (Liker scale)

    Time frame: 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)

Other outcomes

  1. Procedure time needed (minutes)

    Time frame: Immediately after procedure

    The time to insertion of NG tube (from the nose insertion till reaching the stomach)

  2. number of patients with visualization of the trachea (n, %)

    Time frame: immediately after procedure.

    Evaluate how many patient has trachea miss-insertion under this video-assistance

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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