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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of a Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube：a Randomized Controlled Trial

Conditions
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Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia

Intervention / Treatment
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* Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| M group<br>In M group, patients underwent modified post-pyloric feeding tube bedside placement | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.<br>* Modified post-pyloric feeding tube bedside catheterization as an optimized bedside blind post-pyloric tube placement, significantly shortened the time for passing pylorus without causing any severe adverse reactions.<br>|
| C group<br>In C group, patients underwent conventional Corpak protocol | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.<br>* Modified post-pyloric feeding tube bedside catheterization as an optimized bedside blind post-pyloric tube placement, significantly shortened the time for passing pylorus without causing any severe adverse reactions.<br>|
| EM group<br>In EM group, patients received standard electromagnetic guided tube placement. | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.<br>* Modified post-pyloric feeding tube bedside catheterization as an optimized bedside blind post-pyloric tube placement, significantly shortened the time for passing pylorus without causing any severe adverse reactions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of NIT placement | The successful catheterization was defined when the catheter tip was placed behind the pylorus. | 2019.10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time of tube insertion | The time spent on the catheterization. | 2019.10 |