Video Assisted System for Nasogastric Tube Placement

NCT ID: NCT05486286

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach.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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral Nutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

NCKU-NG system

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chiao-Hsiung Chuang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chiao-Hsiung Chuang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal medicine, National Cheng-Kung University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chuang Chiao-Hsiung

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B-BR-111-006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Facilitation of NGT Insertion
NCT02764632 COMPLETED NA