Congenital Heart DiseaseNCT06650787
Application of Ultrasound Technique in Locating the End of the Gastric Tube in Children Aged 0-6 Years
A study testing Ultrasound was used to locate the end of the gastric tube and Conventional placing nasogastric tube group in people with Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years Read more about this study
- Who is it for?
- Ages 1 day to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Ultrasound was used to locate the end of the gastric tube and Conventional placing nasogastric tube group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 30 Jul 2025
- Phase
- Interventional
- 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 1 day to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with CHD who needed gastric tube in CCU were admitted
- children aged 0-6 years
- Informed consent of parents
Who cannot join
- Children with delayed sternal closure
- The parents had cognitive impairment and mental disorders
Trial locations and contacts
1 site in 1 country.
China1 site
CICU,Cardiovascular Center,Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: To Study the Application of Bedside Ultrasound in Gastric Tube Placement and Determination of the Position of the End of the Gastric Tube in Children Aged 0 to 6 Years With Congenital Heart Disease
Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years
Read the detailed description
Bedside blind insertion is the most common method for gastric tube indwelling in clinical practice. The key problem is that the position of the tube cannot be accurately determined in real time.Bedside ultrasound has become a common medical technology, and resources are easy to obtain. Therefore, bedside ultrasound has the advantages of fast, accurate, real-time repeatable, and non-invasive in determining the position of the end of the indwelling gastric tube.The purpose of this study is to investigate the accuracy of bedside ultrasound in guiding gastric tube placement and judging the position of the end of the tube in children with CHD aged 0-6 years. To explore the feasibility and effectiveness of bedside ultrasound guided gastric tube placement during perioperative period in children with congenital heart disease (CHD), this study plans to procedure the prospective randomized controlled study.
- Conditions
- Congenital Heart Disease
- Being tested
- Ultrasound was used to locate the end of the gastric tube, Conventional placing nasogastric tube group
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound was used to locate the end of the gastric tubeOther
- Inform the family of the purpose and method of using bedside ultrasound to guide the placement of the gastric tube, and determine the position of the end of the tube.
- The ultrasound machine was connected to the power supply and placed on the right side of the patient.
- Select the appropriate type of gastric tube and measure the length of the indwelling gastric tube by nursing staff before inserting the tube.
- Nurses who had been trained in ultrasound performed ultrasound judgment on the neck and abdomen of the children. Sonographers, intensive care physicians and nursing staff jointly judged the ultrasound images.
- Conventional judgment method was used to determine the position of gastric tube
- Bedside chest radiography, with results obtained by a radiologist.
- Keep your child safe at all times.
Conventional placing nasogastric tube groupOther
- Choose the appropriate type of gastric tube, and measure the length of the indwelling gastric tube by the nursing staff before the tube insertion.
- The gastric tube was inserted by the conventional blind insertion method.
- The conventional judgment method was used to determine the position of the gastric tube.
- Bedside chest radiography, with results obtained by a radiologist.
- Keep your child safe at all times.
| Study group | Role | What they receive |
|---|---|---|
| According to the ultrasonic images give into stomach tube group | Experimental | According to the ultrasonic images give into stomach tube group Receives: Other: Ultrasound was used to locate the end of the gastric tube |
| Conventional placing nasogastric tube group | Active comparator | Conventional placing nasogastric tube group Receives: Other: Conventional placing nasogastric tube group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of accurate gastric tube placement
Accuracy of gastric tube placement is defined as proportion of accurate gastric tube placement (The tip of the nasogastric tube is positioned within the body or antrum of the stomach).
Measured: The gastric tube is placed within ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start12 Dec 2023
- Primary completion30 Jun 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650787
- Sponsor's protocol ID
- FNF202333
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Application of Bedside Ultrasound in Gastric Tube Placement and Determination of the Position of the End of the Gastric Tube in Children Aged 0 to 6 Years With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06650787
- Acronym / sponsor ID
- FNF202333
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 21 Oct 2024 (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.
Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years
Detailed description
Bedside blind insertion is the most common method for gastric tube indwelling in clinical practice. The key problem is that the position of the tube cannot be accurately determined in real time.Bedside ultrasound has become a common medical technology, and resources are easy to obtain. Therefore, bedside ultrasound has the advantages of fast, accurate, real-time repeatable, and non-invasive in determining the position of the end of the indwelling gastric tube.The purpose of this study is to investigate the accuracy of bedside ultrasound in guiding gastric tube placement and judging the position of the end of the tube in children with CHD aged 0-6 years. To explore the feasibility and effectiveness of bedside ultrasound guided gastric tube placement during perioperative period in children with congenital heart disease (CHD), this study plans to procedure the prospective randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| According to the ultrasonic images give into stomach tube group | Experimental | Other: Ultrasound was used to locate the end of the gastric tubeAccording to the ultrasonic images give into stomach tube group |
| Conventional placing nasogastric tube group | Active comparator | Other: Conventional placing nasogastric tube groupConventional placing nasogastric tube group |
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with CHD who needed gastric tube in CCU were admitted
- children aged 0-6 years
- Informed consent of parents
Key exclusion criteria (2 listed)
- Children with delayed sternal closure
- The parents had cognitive impairment and mental disorders
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 |
|---|---|---|
| Ultrasound was used to locate the end of the gastric tube1. Inform the family of the purpose and method of using bedside ultrasound to guide the placement of the gastric tube, and determine the position of the end of the tube. 2. The ultrasound machine was connected to the power supply and placed on the right side of the patient. 3. Select the appropriate type of gastric tube and measure the length of the indwelling gastric tube by nursing staff before inserting the tube. 4. Nurses who had been trained in ultrasound performed ultrasound judgment on the neck and abdomen of the children. Sonographers, intensive care physicians and nursing staff jointly judged the ultrasound images. 5. Conventional judgment method was used to determine the position of gastric tube 6. Bedside chest radiography, with results obtained by a radiologist. 7. Keep your child safe at all times. | Other | According to the ultrasonic images give into stomach tube group |
| Conventional placing nasogastric tube group1. Choose the appropriate type of gastric tube, and measure the length of the indwelling gastric tube by the nursing staff before the tube insertion. 2. The gastric tube was inserted by the conventional blind insertion method. 3. The conventional judgment method was used to determine the position of the gastric tube. 4. Bedside chest radiography, with results obtained by a radiologist. 5. Keep your child safe at all times. | Other | Conventional placing nasogastric tube group |
Primary outcome
Proportion of accurate gastric tube placement
Time frame: The gastric tube is placed within ten minutes
Accuracy of gastric tube placement is defined as proportion of accurate gastric tube placement (The tip of the nasogastric tube is positioned within the body or antrum of the stomach).
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 6 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound was used to locate the end of the gastric tube and Conventional placing nasogastric tube group in people with Congenital Heart Disease, run by Children's Hospital of Fudan University at 1 site in China.
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 2 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Proportion of accurate gastric tube placement (time frame: The gastric tube is placed within ten minutes). 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 6 Jul 2026.