Clinical trial NCT05486286: Video Assisted System for Nasogastric Tube Placement
Official title: Clinical Study of a Real-time Video-assisted System for Nasogastric Tube Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 In cases where misplacement into the trachea was detected, the feeding tube was carefully withdrawn and reinserted into stomach.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

Eligibility criteria: 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.

Primary outcomes:
measure: The successful rate (percent) of gastric placement of feeding tubes
timeFrame: up to 24 hours after chest X-ray
Secondary outcomes:
measure: opearator evaluation (Liker scale)
timeFrame: immediately after procedure
Other outcomes:
measure: Procedure time needed (minutes)
timeFrame: Immediately after procedure
measure: number of patients with visualization of the trachea (n, %)
timeFrame: immediately after procedure.
Locations:
city: Tainan
country: Taiwan
facility: Chuang Chiao-Hsiung
Study officials:
affiliation: Department of Internal medicine, National Cheng-Kung University Hospital
name: Chiao-Hsiung Chuang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: