Comparing Two Methods to Measure Nasogastric Tube Length

NCT ID: NCT06982495

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this clinical trial is to learn if using a novel nasogastric tube assisted placement system (NCKU-NG system) can more accurately place the nasogastric tube at the optimal position in the stomach compared to conventional blind insertion techniques in adult inpatients requiring nasogastric tube placement. The main questions it aims to answer are:

• Does the NCKU-NG system improve the accuracy of nasogastric tube placement at the optimal gastric position compared to standard blind insertion?
• Does the NCKU-NG system reduce the rate of misplacement (such as entry into the airway or inadequate gastric depth), number of repeated attempts, and complication rate compared to the conventional method?
• Can estimation of nasogastric tube length using the NCKU-NG system provide a more reliable reference than external measurement or X-ray?

Researchers will compare patients randomized to nasogastric tube insertion with the NCKU-NG system (intervention arm) versus conventional blind insertion following standard external measurement methods (control arm) to see if the NCKU-NG system improves placement accuracy and reduces adverse events.

Participants will:

• Be randomized to one of two groups:

• Intervention group: Receive nasogastric tube insertion using the NCKU-NG system (video-assisted real-time visualization, with active confirmation of passage through the esophagogastric junction and final position in the stomach based on sidehole location).
• Control group: Receive traditional nasogastric tube blind bedside insertion based on standard measurement (eg. Nose-Earlobe-Xiphoid + 10 cm).
• All procedures will use the same material nasogastric tube (16 French polyurethane radiopaque tube).
• Undergo confirmation of tube position by X-ray within 8 hours post-insertion for both groups.
• Have the following outcomes assessed:

• Placement accuracy (percentage of tubes placed at optimal predefined gastric position)
• Number of placement attempts and failures
• Rate of inadvertent airway or inadequate placement
• Incidence of complications (e.g., aspiration, pneumothorax, gastrointestinal tract injury)
• Correlation between video-assisted measurement and X-ray estimation of intragastric length

Conditions

Intubation, Nasogastric; Intubation Intraesophageal; Intubation Depth; Intubation Times; Intubation; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NCKU-NG system

Receive nasogastric tube insertion using the NCKU-NG system (video-assisted real-time visualization, with active confirmation of passage through the esophagogastric junction and final position in the stomach based on sidehole location)

Group Type: EXPERIMENTAL

NCKU-NG system

Intervention Type: DEVICE

Nasogastric tube insertion with a novel nasogastric tube assisted placement system (NCKU-NG system)

Conventional blind insertion

Receive traditional nasogastric tube blind bedside insertion based on standard measurement (eg. Nose-Earlobe-Xiphoid + 10 cm)

Group Type: ACTIVE_COMPARATOR

Conventional blind insertion

Intervention Type: OTHER

Conventional blind insertion following standard external measurement methods (eg. Nose-Earlobe-Xiphoid + 10 cm)

Interventions

NCKU-NG system

Nasogastric tube insertion with a novel nasogastric tube assisted placement system (NCKU-NG system)

Intervention Type: DEVICE

Conventional blind insertion

Conventional blind insertion following standard external measurement methods (eg. Nose-Earlobe-Xiphoid + 10 cm)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (aged ≥18 years)
• Patients requiring nasogastric tube placement
• Patients who are hospitalized

Exclusion Criteria

• Patients with a chest wound that prevents palpation of the xiphoid process
• Patients who have had a gastrectomy
• Patients with a gastric tumor
• Patients with a head and neck tumor
• Patients who are agitated and difficult to place the nasogastric tube
• Patients with abnormal esophageal structure
• Patients with a basilar skull fracture
• Patients with acute upper gastrointestinal bleeding
• Patients with an expected lifespan of less than 48 hours
• Patients who cannot undergo an X-ray confirmation (e.g., pregnant women)
• Patients with unstable blood pressure (mean arterial pressure < 65 mmHg)
• Patients with ischemic, perforated, or obstructed bowel
• Patients with high-output fistula/ostomy
• Patients using photosensitive drugs
• Critically ill patients
• Patients with acute needs as determined by the attending physician
• Patients with a Glasgow Coma Scale score < 8

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chiao-Hsiung Chuang

Head of Gastroenterology and Hepatology, Medical Doctor (M.D.), Doctor of Philosophy (Ph.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

A-BR-113-021

Identifier Type: -

Identifier Source: org_study_id