Intubation, NasogastricNCT06982495
Comparing Two Methods to Measure Nasogastric Tube Length
A study testing NCKU-NG system and Conventional blind insertion in people with Intubation, Nasogastric and Intubation Intraesophageal, run by National Cheng-Kung University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Nasogastric, Intubation Intraesophageal, Intubation Depth
- What is being tested?
- NCKU-NG system and Conventional blind insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged ≥18 years)
- Patients requiring nasogastric tube placement
- Patients who are hospitalized
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
Official title: Comparing Two Methods for Estimating Nasogastric Tube Length: A Randomized Control Study
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?
Read more
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
- Being tested
- NCKU-NG system, Conventional blind insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCKU-NG systemDevice
Nasogastric tube insertion with a novel nasogastric tube assisted placement system (NCKU-NG system)
Conventional blind insertionOther
Conventional blind insertion following standard external measurement methods (eg. Nose-Earlobe-Xiphoid + 10 cm)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Conventional blind insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placement accuracy
Percentage of tubes placed at optimal predefined gastric position
Measured: 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
Measured: The moment after the completion of an nasogastric tube insertion
Number of placement attempts
Measured: The moment after the completion of an nasogastric tube insertion
Insertion time
Measured: The moment after the completion of an nasogastric tube insertion
Incidence of complications
Measured: A week after the completion of an nasogastric tube insertion
Correlation between video-assisted measurement and X-ray estimation of intragastric length
Measured: Within 8 hours after the completion of an nasogastric tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, NasogastricStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiao-Hsiung Chuang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982495
- Sponsor's protocol ID
- A-BR-113-021
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Methods for Estimating Nasogastric Tube Length: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT06982495
- Acronym / sponsor ID
- A-BR-113-021
- Conditions
- Intubation, Nasogastric, Intubation Intraesophageal, Intubation Depth, Intubation Times, Intubation; Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCKU-NG system | Experimental | Device: NCKU-NG systemReceive 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) |
| Conventional blind insertion | Active comparator | Other: Conventional blind insertionReceive traditional nasogastric tube blind bedside insertion based on standard measurement (eg. Nose-Earlobe-Xiphoid + 10 cm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (aged ≥18 years)
- Patients requiring nasogastric tube placement
- Patients who are hospitalized
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCKU-NG systemNasogastric tube insertion with a novel nasogastric tube assisted placement system (NCKU-NG system) | Device | NCKU-NG system |
| Conventional blind insertionConventional blind insertion following standard external measurement methods (eg. Nose-Earlobe-Xiphoid + 10 cm) | Other | Conventional blind insertion |
Primary outcome
Placement accuracy
Time frame: Within 8 hours after the completion of a nasogastric tube insertion; that is, after the X-ray was taken
Percentage of tubes placed at optimal predefined gastric position
5 secondary outcomes
First-attempt success rate
Time frame: The moment after the completion of an nasogastric tube insertion
Number of placement attempts
Time frame: The moment after the completion of an nasogastric tube insertion
Insertion time
Time frame: The moment after the completion of an nasogastric tube insertion
Incidence of complications
Time frame: A week after the completion of an nasogastric tube insertion
Correlation between video-assisted measurement and X-ray estimation of intragastric length
Time frame: Within 8 hours after the completion of an nasogastric tube insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NCKU-NG system and Conventional blind insertion in people with Intubation, Nasogastric and Intubation Intraesophageal, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placement accuracy (time frame: Within 8 hours after the completion of a nasogastric tube insertion; that is, after the X-ray was taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.