NCT05486286

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

August 2, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 26, 2022

Last Update Submit

July 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • opearator evaluation (Liker scale)

    immediately after procedure

Other Outcomes (2)

  • Procedure time needed (minutes)

    Immediately after procedure

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

    immediately after procedure.

Study Arms (1)

video assisted NG placement

EXPERIMENTAL

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

Interventions

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.

video assisted NG placement

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuang Chiao-Hsiung

Tainan, 704, Taiwan

Location

Study Officials

  • Chiao-Hsiung Chuang, M.D.

    Department of Internal medicine, National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 3, 2022

Study Start

August 2, 2022

Primary Completion

May 3, 2023

Study Completion

May 10, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations