One Brand-new Maneuver to Place Nasoenteric Tube

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

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.

Study Overview

• Status: Unknown
• Conditions: Nutrient Intake Disorder
• Intervention / Treatment: Device: ultrathın esophagogastroduodenoscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hua-lien County
    • Hualien City, Hua-lien County, Taiwan, 97002
      • Recruiting
      • Tzu-chi Hospital
      • Contact: Jen S Lin, VS; Phone Number: 13224 886-3-8561825; Email: labyrinth68306830@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Naso-enteric tube placement; The participants needed nutrition from naso-enteric tube feeding are enrolled into this study. Double-blind was not needed here.	Device: ultrathın esophagogastroduodenoscope; Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure time	The procedure times to place the tube are recorded	wıthın 20 mınutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the tıme of naso-enterıc tube usage	The tıme of the naso-enteric tube was recorded in day	within 90 days

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Study Director: Jen S Lin, VS, Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB106-10-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No