Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia Clinical Trial
Official title:
Efficacy and Safety of a Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tubeļ¼a Randomized Controlled Trial
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 |
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 |
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Second Affiliated Hospital, School of Medicine, Zhejiang University |
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 |