Nutritional Support, Catheterization, Post-pyloric Feeding Tube, DysphagiaNCT04608071
A Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube.
An observational study of Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia
- What is being tested?
- A modified method for blind bedside placement of post-pyloric feeding tube.
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Being tested
- A modified method for blind bedside placement of post-pyloric feeding tube.
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A modified method for blind bedside placement of post-pyloric feeding tube.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| M group | In M group, patients underwent modified post-pyloric feeding tube bedside placement Receives: Procedure: A modified method for blind bedside placement of post-pyloric feeding tube. | |
| C group | In C group, patients underwent conventional Corpak protocol Receives: Procedure: A modified method for blind bedside placement of post-pyloric feeding tube. | |
| EM group | In EM group, patients received standard electromagnetic guided tube placement. Receives: Procedure: A modified method for blind bedside placement of post-pyloric feeding tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of NIT placement
The successful catheterization was defined when the catheter tip was placed behind the pylorus.
Measured: 2019.10
Secondary outcomes (1)
Operation time of tube insertion
The time spent on the catheterization.
Measured: 2019.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Support, Catheterization, Post-pyloric Feeding Tube, DysphagiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiong Bing, M.M.D, Principal investigator, Department of Rehabilitation, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, PR China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608071
- Sponsor's protocol ID
- 2020-273
- Status last verified
- Apr 2020
- First submitted
- 27 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04608071
- Acronym / sponsor ID
- 2020-273
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M group | – | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.In M group, patients underwent modified post-pyloric feeding tube bedside placement |
| C group | – | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.In C group, patients underwent conventional Corpak protocol |
| EM group | – | Procedure: A modified method for blind bedside placement of post-pyloric feeding tube.In EM group, patients received standard electromagnetic guided tube placement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | C group, EM group, M group |
Primary outcome
The success rate of NIT placement
Time frame: 2019.10
The successful catheterization was defined when the catheter tip was placed behind the pylorus.
1 secondary outcome
Operation time of tube insertion
Time frame: 2019.10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiong Bing, M.M.D principal investigator
Department of Rehabilitation, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, PR China.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of NIT placement (time frame: 2019.10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.