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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04608071
Enrollment
99
Registered
2020-10-29
Start date
2017-01-01
Completion date
2019-10-30
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREA 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
The success rate of NIT placement2019.10The successful catheterization was defined when the catheter tip was placed behind the pylorus.

Secondary

MeasureTime frameDescription
Operation time of tube insertion2019.10The time spent on the catheterization.

Other

MeasureTime frameDescription
The time for passing pylorus and the depth of insertion2019.10The time the catheterization passes through the pylorus.
Serious complications2019.10asphyxiation, hemoptysis, and exacerbation of aspiration pneumonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026