Nasogastric TubeNCT04104295
The Use of Ultrasound in Nasogastric Tube Placement in Children Admitted to the Pediatric ICU
A study testing Ultrasound following X-ray in people with Nasogastric Tube, run by Yale University.
Trial summary
The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Nasogastric Tube
- What is being tested?
- Ultrasound following X-ray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2020to 31 Jan 2021
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PICU patient undergoing routine NGT insertion by nursing staff
Who cannot join
- Any contraindication for US probe placement such as skin infection and abdominal wounds.
- Hemodynamically unstable patients.
- Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.
About this study
Official title: The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study
The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).
Read the detailed description
Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR.
- Conditions
- Nasogastric Tube
- Being tested
- Ultrasound following X-ray
- Keywords
- nasogastric tube, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound following X-rayDiagnostic test
Also called Ultrasound
A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound following X-ray | Experimental | An ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results. Receives: Diagnostic Test: Ultrasound following X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct placement of NG tube
The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read.
Measured: Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start24 Mar 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Why it stopped: Study never began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric TubeStudies of the same condition, open and under way.
- More trials run by Yale 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eitan Neeman, MD, Principal investigator, Yale University - MEDPED Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104295
- Sponsor's protocol ID
- 2000026488
- Status last verified
- Apr 2021
- First submitted
- 24 Sep 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasound to Determine Correct Nasogastric Tube Placement in Children Admitted to the Pediatric ICU: a Pilot Study
- ClinicalTrials.gov ID
- NCT04104295
- Acronym / sponsor ID
- 2000026488
- Conditions
- Nasogastric Tube
- Keywords
- nasogastric tube, ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 24 Mar 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 26 Sep 2019 (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.
The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).
Detailed description
Currently, the standard of care is to routinely obtain an X-ray (XR) after every nasogastric tube (NGT) placement in the pediatric intensive care unit (PICU). After obtaining informed consent and the child's assent, a short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine XR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound following X-ray | Experimental | Diagnostic Test: Ultrasound following X-rayAn ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- PICU patient undergoing routine NGT insertion by nursing staff
Key exclusion criteria (3 listed)
- Any contraindication for US probe placement such as skin infection and abdominal wounds.
- Hemodynamically unstable patients.
- Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.
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 following X-rayAlso: UltrasoundA short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report. | Diagnostic test | Ultrasound following X-ray |
Primary outcome
Correct placement of NG tube
Time frame: Up to 10 minutes
The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Eitan Neeman, MD principal investigator
Yale University - MEDPED Critical Care
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound following X-ray in people with Nasogastric Tube, run by Yale University.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correct placement of NG tube (time frame: Up to 10 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 20 Apr 2021.