Comparing Two Methods to Measure Nasogastric Tube Length

NCT06982495 | Not Yet Recruiting

• 1 other identifier: A-BR-113-021
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Placement accuracy

  Percentage of tubes placed at optimal predefined gastric position

  Within 8 hours after the completion of a nasogastric tube insertion; that is, after the X-ray was taken

Secondary Outcomes (5)

• First-attempt success rate

  The moment after the completion of an nasogastric tube insertion

• Number of placement attempts

  The moment after the completion of an nasogastric tube insertion

• Insertion time

  The moment after the completion of an nasogastric tube insertion

• Incidence of complications

  A week after the completion of an nasogastric tube insertion

• Correlation between video-assisted measurement and X-ray estimation of intragastric length

  Within 8 hours after the completion of an nasogastric tube insertion

Study Arms (2)

NCKU-NG system

EXPERIMENTAL

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)

Device: NCKU-NG system

Conventional blind insertion

ACTIVE COMPARATOR

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

Other: Conventional blind insertion

Interventions

NCKU-NG system DEVICE

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

NCKU-NG system

Conventional blind insertion OTHER

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

Conventional blind insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology and Hepatology, Medical Doctor (M.D.), Doctor of Philosophy (Ph.D.)

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05