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Completed

NCT Number: NCT04608071

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

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.

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Key information

Conditions

Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  1. Operation time of tube insertion

    Time frame: 2019.10

    The time spent on the catheterization.

Other outcomes

  1. The time for passing pylorus and the depth of insertion

    Time frame: 2019.10

    The time the catheterization passes through the pylorus.

  2. Serious complications

    Time frame: 2019.10

    asphyxiation, hemoptysis, and exacerbation of aspiration pneumonia

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2020
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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