A Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube.
October 29, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Efficacy and Safety of a Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube：a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
99
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Sixty-three patients with dysphagia from Department of Rehabilitation, the Second Affiliated Hospital of Zhejiang University School on January 1, 2017 to January 1, 2019.
All the patients included in this study were in accordance with the guide of diagnosis and treatment of swallowing disorders of diagnostic criteria.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
M group
In M group, patients underwent modified post-pyloric feeding tube bedside placement
|
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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The success rate of NIT placement
Time Frame: 2019.10
|
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
Time Frame: 2019.10
|
The time spent on the catheterization.
|
2019.10
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The time for passing pylorus and the depth of insertion
Time Frame: 2019.10
|
The time the catheterization passes through the pylorus.
|
2019.10
|
|
Serious complications
Time Frame: 2019.10
|
asphyxiation, hemoptysis, and exacerbation of aspiration pneumonia
|
2019.10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiong Bing, M.M.D, Department of Rehabilitation, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, PR China.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
October 27, 2020
First Submitted That Met QC Criteria
October 27, 2020
First Posted (Actual)
October 29, 2020
Study Record Updates
Last Update Posted (Actual)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-273
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
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