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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04608071
Other study ID # 2020-273
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date October 30, 2019

Study information

Verified date April 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date October 30, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Other The time for passing pylorus and the depth of insertion The time the catheterization passes through the pylorus. 2019.10
Other Serious complications asphyxiation, hemoptysis, and exacerbation of aspiration pneumonia 2019.10
Primary The success rate of NIT placement The successful catheterization was defined when the catheter tip was placed behind the pylorus. 2019.10
Secondary Operation time of tube insertion The time spent on the catheterization. 2019.10