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Clinical Trials/NCT04608071
NCT04608071
Completed
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University0 sites99 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
99
Primary Endpoint
The success rate of NIT placement
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
October 30, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The success rate of NIT placement

Time Frame: 2019.10

The successful catheterization was defined when the catheter tip was placed behind the pylorus.

Secondary Outcomes

  • Operation time of tube insertion(2019.10)

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