A Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube.

Completed

• Conditions: Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia
• Interventions: Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.

• Registration Number: NCT04608071
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

To compare efficacy and safety of a new modified post-pyloric feeding tube bedside catheterization with Corpak 10-10-10 protocol and electromagnetic guided catheterization for treatment of patients with dysphagia and at high-risk of aspiration pneumonia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. A total of 63 patients were treated with the non-gravity type CORFLO gastrointestinal feeding tube between 2017.1 and 2019.1 using different procedures: in the M group, patients underwent modified post-pyloric feeding tube bedside placement; in C group, patients underwent conventional Corpak protocol; in EM group, patients received standard electromagnetic guided tube placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-10-30
• Status Verified: 2020-04
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-29
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• All patients had dysphagia that could not be alleviated within 48 hours
• High-risk status with aspiration pneumonia, including consciousness disorder caused by various diseases, severe dementia, bed rest, gastroesophageal reflux, hiccup, gastric retention, achalasia of pyloric.
• Can't receive nasogastric tube feeding.

Exclusion Criteria

• The previous history of upper abdominal surgery.
• Gastroduodenal ulcer and esophagogastric varices;
• Severe sinusitis and nasal bone fracture;
• Patients with recent gastrointestinal bleeding, intestinal obstruction, ischemic bowel disease, and epistaxis;
• Patients with electromagnetically-guided catheterization should additionally exclude implantable cardiac defibrillator, implantable cardiac pacemaker or diaphragm pacemaker.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EM group	A modified method for blind bedside placement of post-pyloric feeding tube.	In EM group, patients received standard electromagnetic guided tube placement.
M group	A modified method for blind bedside placement of post-pyloric feeding tube.	In M group, patients underwent modified post-pyloric feeding tube bedside placement
C group	A modified method for blind bedside placement of post-pyloric feeding tube.	In C group, patients underwent conventional Corpak protocol

Primary Outcome Measures

Name	Time	Method
The success rate of NIT placement	2019.10	The successful catheterization was defined when the catheter tip was placed behind the pylorus.

Secondary Outcome Measures

Name	Time	Method
Operation time of tube insertion	2019.10	The time spent on the catheterization.