Comparing Two Methods to Measure Nasogastric Tube Length
- Conditions
- Intubation, NasogastricIntubation IntraesophagealIntubation DepthIntubation TimesIntubation; Complication
- Registration Number
- NCT06982495
- Lead Sponsor
- National Cheng-Kung University Hospital
- Brief Summary
The goal of this clinical trial is to learn if using a novel nasogastric tube (NGT) assisted placement system (NCKU-NG system) can more accurately place the NGT at the optimal position in the stomach compared to conventional blind insertion techniques in adult inpatients requiring NGT placement. The main questions it aims to answer are:
* Does the NCKU-NG system improve the accuracy of NGT 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 NGT length using the NCKU-NG system provide a more reliable reference than external measurement or chest X-ray?
Researchers will compare patients randomized to NGT 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 NGT insertion using the NCKU-NG system (video-assisted real-time visualization, with active confirmation of passage through the esophagogastric junction \[EGJ\] and final position in the stomach based on sidehole location).
* Control group: Receive traditional NGT blind bedside insertion based on standard measurement (eg. NEX+10 cm).
* All procedures will use the same material NGT (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, GI tract injury)
* Correlation between video-assisted measurement and chest X-ray estimation of intragastric length
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 220
- Adults (aged ≥18 years)
- Patients requiring nasogastric tube placement
- Patients who are hospitalized
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Placement accuracy Within 8 hours after the completion of an NGT insertion; that is, after the x-ray was taken Percentage of tubes placed at optimal predefined gastric position
- Secondary Outcome Measures
Name Time Method First-attempt success rate The moment after the completion of an NGT insertion Number of placement attempts The moment after the completion of an NGT insertion Insertion time The moment after the completion of an NGT insertion Incidence of complications A week after the completion of an NGT insertion Correlation between video-assisted measurement and X-ray estimation of intragastric length Within 8 hours after the completion of an NGT insertion