One Brand-new Maneuver to Place Nasoenteric Tube

Nutrient Intake Disorder Clinical Trial

Official title:

Tzu-chi General Hospital,Hualien County,Taiwan,ROC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222179
• Other study ID #: IRB106-10-A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Buddhist Tzu Chi General Hospital
• Contact: Jen S Lin, VS
• Phone: 886-3-8561825
• Email: labyrinth68306830[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Naso-enteric tube feeding is necessary for certain patients. Many methods are used to place a naso-enteric tube, such as bed-side blind method, fluoroscopy method and guide-wire method. INvestigators aim to introduce a safe, non-expensive and fast method to insert a silicon naso-gastric (NG) tube into the small intestine.

Description:

Investigators tied a 1-cm surgical suture at the tip of a 16 French silicon NG tube (120 cm long, cost 5 US dollars). One conventional EGD (diameter 2.8 mm) biopsy forceps was inserted into the lumen as a strengthened stylet. Then investigators inserted a biopsy forceps (diameter 2.0 mm) and protruded a little out of the working channel of an ultrathin EGD scope (Fujinon EG 530 N, diameter 5.9 mm) to grasp the suture. The ultrathin EGD and NG tube were parallelly pushed into a selected nostril after adequate decongestive anesthesia (Epinephrine 0.3% + Lidocaine 5%) into the small intestine as deep as possible to the jejunum.

Being placed to the small intestine as far as possible, the NG tube was released and the ultrathin EGD scope withdrew. When the scope was pulled backwards from the stomach, the shape/layout of a NG-tube could be simultaneously monitored and adjusted. At last, the EGD biopsy forceps (2.8 mm) inside the NG tube was removed. With this method, in real life, a plain film is not necessary to confirm the NG tube position. However, for study purpose, a KUB film was taken to check the NG tube position.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Esophageal obstruction

2. Gastric outlet obstruction

3. Duodenal obstruction

4. Pancreatitis

5. Gastroparesis -

Exclusion Criteria:

• (1)Coagulopathy (2)Deviation of nasal septa (3)Conscious disturbance

Related Conditions & MeSH terms

• Nutrient Intake Disorder

Intervention

Device:
• ultrathin esophagogastroduodenoscope
Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity

Locations

Country	Name	City	State
Taiwan	Tzu-chi Hospital	Hualien City	Hua-lien County

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure time	The procedure times to place the tube are recorded	within 20 minutes
Secondary	the time of naso-enteric tube usage	The time of the naso-enteric tube was recorded in day	within 90 days