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

NCT ID: NCT04608071

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-10-30

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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M group

In M group, patients underwent modified post-pyloric feeding tube bedside placement

A modified method for blind bedside placement of post-pyloric feeding tube.

Intervention Type PROCEDURE

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.

C group

In C group, patients underwent conventional Corpak protocol

A modified method for blind bedside placement of post-pyloric feeding tube.

Intervention Type PROCEDURE

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.

EM group

In EM group, patients received standard electromagnetic guided tube placement.

A modified method for blind bedside placement of post-pyloric feeding tube.

Intervention Type PROCEDURE

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.

Interventions

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A modified method for blind bedside placement of post-pyloric feeding tube.

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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiong Bing, M.M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, PR China.

Other Identifiers

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2020-273

Identifier Type: -

Identifier Source: org_study_id