Gastrostomy Tube Site ComplicationNCT04331873
Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients
A study testing Ultrasound in people with Gastrostomy Tube Site Complication and Gastrostomy Complications, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if ultrasound can be used effectively to confirm location of gastrostomy tube (G-tube) placement in place of a study in which contrast is flushed through the G-tube and placement is checked with X-ray. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Gastrostomy Tube Site Complication, Gastrostomy Complications
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Feb 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Dislodged gastrostomy tube requiring contrast injection to confirm proper gastrostomy replacement
Who cannot join
- No ultrasound technician present in hospital
- Non-functioning ultrasound equipment (e.g. due to hardware issues)
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Hospital
Memphis, Tennessee, 38103
About this study
Official title: Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients: Can we Replace Contrast Injection With Ultrasound
The purpose of this study is to evaluate if ultrasound can be used effectively to confirm location of gastrostomy tube (G-tube) placement in place of a study in which contrast is flushed through the G-tube and placement is checked with X-ray. A G-tube is a tube inserted through the abdomen and delivers nutrition directly into the stomach.
Read the detailed description
The purpose of this study is to determine if ultrasound is a safe and reliable way to confirm the proper placement of a dislodged gastrostomy tube in a pediatric emergency department.
In the case of emergent replacement of dislodged gastrostomy tubes, the emergency department currently obtains a contrast injection of the gastrostomy tube to confirm proper replacement in patients who recently had gastrostomy surgically placed or those who require dilation/have difficult replacement as per the pediatric surgery protocol. In this study, an ultrasound (US) will be obtained by an US technician to assess if the gastrostomy tube is in the proper location. Once this study has been obtained, the patient will undergo the typical contrast injection of the gastrostomy tube to confirm placement. The sensitivity and specificity of ultrasound to the current gold standard of contrast injection will be compared.
Ultrasound (US) has the benefit of having no radiation exposure for the patient. In patients anticipated to have multiple emergency department visits a year for gastrostomy complications, using ultrasound as opposed to contrast injection may make a significant impact on accumulated radiation exposure.
The patient population will be composed of children ages 0 to 21 years that visit Le Bonheur Children's Hospital Emergency Department (Memphis, TN) for replacement of a dislodge gastrostomy tube who require contrast injection to confirm proper replacement. Once it is determined that imaging is needed to confirm replacement, the patient and legally authorized representative (LAR) will be consented for the study. The determination for contrast injection is made per protocol when gastrostomy was placed within the last 3 months or when a difficult replacement occurs (i.e. one requiring stoma dilation). A procedure checklist will be used for the provider to complete for the procedure that can be used to better evaluate the amount of attempts made to replace the tube and different methods used prior to decision to pursue contrast injection.
The LAR's will be consented for the study once they are in their private exam room in the ER. Consent, and assent when applicable, will be obtained for the study as well as discussion of risks of improper gastrostomy placement and it's risk of infection. However, this will not be deviating from the current standard of care for emergent gastrostomy replacement.
When patient goes to the radiology department, they will have an US performed by US technician who will inject Pedialyte solution through the gastrostomy and visualize fluid entering the stomach in sagittal and transverse views. These ultrasound images will not have any effect on the patient's ER course in real time and will be read by the attending radiologist the following day. Furthermore, the risk of Pedialyte injection into an improperly placed gastrostomy tube has already been discussed with pediatric surgery and radiology and is determined to be of no risk of harm to the patient as any misplaced tube would require confirmation with contrast injection at this point in time. The patient will then have contrast injection performed as per the standard of care to confirm placement and then will return to their ER exam room for further management during their visit based on the results of their contrast injection study.
- Being tested
- Ultrasound
- Keywords
- gastrostomy, dislodged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Also called US
An ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | An ultrasound will be obtained to evaluate placement of the gastrostomy tube prior to obtaining the standard contrast injection Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of gastrostomy tube placement
Ultrasound will be obtained in addition to contrast injection to determine gastrostomy tube placement
Measured: This procedure is brief (<5-10 minutes) and will be performed after gastrostomy tube replacement prior to the patient having the gold standard contrast injection performed before returning to their exam room. This should take no more than one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Aug 2019
- Primary completion18 Nov 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Gastrostomy Tube Site ComplicationStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Le Bonheur Children's Hospital
- Responsible party
- Principal investigator, Cailin Frank, DO, University of Tennessee
- Investigators
- Rudy A Kink, MD, Study director, Le Bonheur Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331873
- Sponsor's protocol ID
- 19-06455-XP
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2019
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dookhoo L, Mahant S, Parra DA, John PR, Amaral JG, Connolly BL. Peritonitis following percutaneous gastrostomy tube insertions in children. Pediatr Radiol. 2016 Sep;46(10):1444-50. doi: 10.1007/s00247-016-3628-5. Epub 2016 May 12.
PubMed 27173980Myatt TC, Medak AJ, Lam SHF. Use of Point-of-Care Ultrasound to Guide Pediatric Gastrostomy Tube Replacement in the Emergency Department. Pediatr Emerg Care. 2018 Feb;34(2):145-148. doi: 10.1097/PEC.0000000000001400.
PubMed 29346232Saavedra H, Losek JD, Shanley L, Titus MO. Gastrostomy tube-related complaints in the pediatric emergency department: identifying opportunities for improvement. Pediatr Emerg Care. 2009 Nov;25(11):728-32. doi: 10.1097/PEC.0b013e3181bec847.
PubMed 19864965Showalter CD, Kerrey B, Spellman-Kennebeck S, Timm N. Gastrostomy tube replacement in a pediatric ED: frequency of complications and impact of confirmatory imaging. Am J Emerg Med. 2012 Oct;30(8):1501-6. doi: 10.1016/j.ajem.2011.12.014. Epub 2012 Feb 4.
PubMed 22306396Tsujimoto H, Tsujimoto Y, Nakata Y, Akazawa M, Kataoka Y. Ultrasonography for confirmation of gastric tube placement. Cochrane Database Syst Rev. 2017 Apr 17;4(4):CD012083. doi: 10.1002/14651858.CD012083.pub2.
PubMed 28414415Wu TS, Leech SJ, Rosenberg M, Huggins C, Papa L. Ultrasound can accurately guide gastrostomy tube replacement and confirm proper tube placement at the bedside. J Emerg Med. 2009 Apr;36(3):280-4. doi: 10.1016/j.jemermed.2007.11.064. Epub 2008 Jul 9.
PubMed 18614327Zamora IJ, Fallon SC, Orth RC, Kim ME, Brandt ML, Lopez ME, Wesson DE, Rodriguez JR. Overuse of fluoroscopic gastrostomy studies in a children's hospital. J Surg Res. 2014 Aug;190(2):598-603. doi: 10.1016/j.jss.2014.05.010. Epub 2014 May 9.
PubMed 24909868Berman L, Hronek C, Raval MV, Browne ML, Snyder CL, Heiss KF, Rangel SJ, Goldin AB, Rothstein DH. Pediatric Gastrostomy Tube Placement: Lessons Learned from High-performing Institutions through Structured Interviews. Pediatr Qual Saf. 2017 Feb 23;2(2):e016. doi: 10.1097/pq9.0000000000000016. eCollection 2017 Mar-Apr.
PubMed 30229155Bhambani S, Phan TH, Brown L, Thorp AW. Replacement of Dislodged Gastrostomy Tubes After Stoma Dilation in the Pediatric Emergency Department. West J Emerg Med. 2017 Jun;18(4):770-774. doi: 10.5811/westjem.2017.3.31796. Epub 2017 Apr 19.
PubMed 28611900Church JT, Speck KE, Jarboe MD. Ultrasound-guided gastrostomy tube placement: A case series. J Pediatr Surg. 2017 Jul;52(7):1210-1214. doi: 10.1016/j.jpedsurg.2017.03.061. Epub 2017 Apr 2.
PubMed 28408076Chenaitia H, Brun PM, Querellou E, Leyral J, Bessereau J, Aime C, Bouaziz R, Georges A, Louis F; WINFOCUS (World Interactive Network Focused On Critical Ultrasound) Group France. Ultrasound to confirm gastric tube placement in prehospital management. Resuscitation. 2012 Apr;83(4):447-51. doi: 10.1016/j.resuscitation.2011.11.035. Epub 2011 Dec 29.
PubMed 22209831Correa JA, Fallon SC, Murphy KM, Victorian VA, Bisset GS, Vasudevan SA, Lopez ME, Brandt ML, Cass DL, Rodriguez JR, Wesson DE, Lee TC. Resource utilization after gastrostomy tube placement: defining areas of improvement for future quality improvement projects. J Pediatr Surg. 2014 Nov;49(11):1598-601. doi: 10.1016/j.jpedsurg.2014.06.015. Epub 2014 Aug 8.
PubMed 25475801
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients: Can we Replace Contrast Injection With Ultrasound
- ClinicalTrials.gov ID
- NCT04331873
- Acronym / sponsor ID
- 19-06455-XP
- Keywords
- gastrostomy, dislodged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Le Bonheur Children's Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 2 Apr 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.
The purpose of this study is to evaluate if ultrasound can be used effectively to confirm location of gastrostomy tube (G-tube) placement in place of a study in which contrast is flushed through the G-tube and placement is checked with X-ray. A G-tube is a tube inserted through the abdomen and delivers nutrition directly into the stomach.
Detailed description
The purpose of this study is to determine if ultrasound is a safe and reliable way to confirm the proper placement of a dislodged gastrostomy tube in a pediatric emergency department.
In the case of emergent replacement of dislodged gastrostomy tubes, the emergency department currently obtains a contrast injection of the gastrostomy tube to confirm proper replacement in patients who recently had gastrostomy surgically placed or those who require dilation/have difficult replacement as per the pediatric surgery protocol. In this study, an ultrasound (US) will be obtained by an US technician to assess if the gastrostomy tube is in the proper location. Once this study has been obtained, the patient will undergo the typical contrast injection of the gastrostomy tube to confirm placement. The sensitivity and specificity of ultrasound to the current gold standard of contrast injection will be compared.
Ultrasound (US) has the benefit of having no radiation exposure for the patient. In patients anticipated to have multiple emergency department visits a year for gastrostomy complications, using ultrasound as opposed to contrast injection may make a significant impact on accumulated radiation exposure.
The patient population will be composed of children ages 0 to 21 years that visit Le Bonheur Children's Hospital Emergency Department (Memphis, TN) for replacement of a dislodge gastrostomy tube who require contrast injection to confirm proper replacement. Once it is determined that imaging is needed to confirm replacement, the patient and legally authorized representative (LAR) will be consented for the study. The determination for contrast injection is made per protocol when gastrostomy was placed within the last 3 months or when a difficult replacement occurs (i.e. one requiring stoma dilation). A procedure checklist will be used for the provider to complete for the procedure that can be used to better evaluate the amount of attempts made to replace the tube and different methods used prior to decision to pursue contrast injection.
The LAR's will be consented for the study once they are in their private exam room in the ER. Consent, and assent when applicable, will be obtained for the study as well as discussion of risks of improper gastrostomy placement and it's risk of infection. However, this will not be deviating from the current standard of care for emergent gastrostomy replacement.
When patient goes to the radiology department, they will have an US performed by US technician who will inject Pedialyte solution through the gastrostomy and visualize fluid entering the stomach in sagittal and transverse views. These ultrasound images will not have any effect on the patient's ER course in real time and will be read by the attending radiologist the following day. Furthermore, the risk of Pedialyte injection into an improperly placed gastrostomy tube has already been discussed with pediatric surgery and radiology and is determined to be of no risk of harm to the patient as any misplaced tube would require confirmation with contrast injection at this point in time. The patient will then have contrast injection performed as per the standard of care to confirm placement and then will return to their ER exam room for further management during their visit based on the results of their contrast injection study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Diagnostic Test: UltrasoundAn ultrasound will be obtained to evaluate placement of the gastrostomy tube prior to obtaining the standard contrast injection |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Dislodged gastrostomy tube requiring contrast injection to confirm proper gastrostomy replacement
Key exclusion criteria (2 listed)
- No ultrasound technician present in hospital
- Non-functioning ultrasound equipment (e.g. due to hardware issues)
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 |
|---|---|---|
| UltrasoundAlso: USAn ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal. | Diagnostic test | Ultrasound |
Primary outcome
Confirmation of gastrostomy tube placement
Time frame: This procedure is brief (<5-10 minutes) and will be performed after gastrostomy tube replacement prior to the patient having the gold standard contrast injection performed before returning to their exam room. This should take no more than one hour
Ultrasound will be obtained in addition to contrast injection to determine gastrostomy tube placement
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 31 Oct 2023.
- Background: PubMed 27173980Dookhoo L, Mahant S, Parra DA, John PR, Amaral JG, Connolly BL. Peritonitis following percutaneous gastrostomy tube insertions in children. Pediatr Radiol. 2016 Sep;46(10):1444-50. doi: 10.1007/s00247-016-3628-5. Epub 2016 May 12.
- Background: PubMed 29346232Myatt TC, Medak AJ, Lam SHF. Use of Point-of-Care Ultrasound to Guide Pediatric Gastrostomy Tube Replacement in the Emergency Department. Pediatr Emerg Care. 2018 Feb;34(2):145-148. doi: 10.1097/PEC.0000000000001400.
- Background: PubMed 19864965Saavedra H, Losek JD, Shanley L, Titus MO. Gastrostomy tube-related complaints in the pediatric emergency department: identifying opportunities for improvement. Pediatr Emerg Care. 2009 Nov;25(11):728-32. doi: 10.1097/PEC.0b013e3181bec847.
- Background: PubMed 22306396Showalter CD, Kerrey B, Spellman-Kennebeck S, Timm N. Gastrostomy tube replacement in a pediatric ED: frequency of complications and impact of confirmatory imaging. Am J Emerg Med. 2012 Oct;30(8):1501-6. doi: 10.1016/j.ajem.2011.12.014. Epub 2012 Feb 4.
- Background: PubMed 28414415Tsujimoto H, Tsujimoto Y, Nakata Y, Akazawa M, Kataoka Y. Ultrasonography for confirmation of gastric tube placement. Cochrane Database Syst Rev. 2017 Apr 17;4(4):CD012083. doi: 10.1002/14651858.CD012083.pub2.
- Background: PubMed 18614327Wu TS, Leech SJ, Rosenberg M, Huggins C, Papa L. Ultrasound can accurately guide gastrostomy tube replacement and confirm proper tube placement at the bedside. J Emerg Med. 2009 Apr;36(3):280-4. doi: 10.1016/j.jemermed.2007.11.064. Epub 2008 Jul 9.
- Background: PubMed 24909868Zamora IJ, Fallon SC, Orth RC, Kim ME, Brandt ML, Lopez ME, Wesson DE, Rodriguez JR. Overuse of fluoroscopic gastrostomy studies in a children's hospital. J Surg Res. 2014 Aug;190(2):598-603. doi: 10.1016/j.jss.2014.05.010. Epub 2014 May 9.
- Results publication: PubMed 30229155Berman L, Hronek C, Raval MV, Browne ML, Snyder CL, Heiss KF, Rangel SJ, Goldin AB, Rothstein DH. Pediatric Gastrostomy Tube Placement: Lessons Learned from High-performing Institutions through Structured Interviews. Pediatr Qual Saf. 2017 Feb 23;2(2):e016. doi: 10.1097/pq9.0000000000000016. eCollection 2017 Mar-Apr.
- Results publication: PubMed 28611900Bhambani S, Phan TH, Brown L, Thorp AW. Replacement of Dislodged Gastrostomy Tubes After Stoma Dilation in the Pediatric Emergency Department. West J Emerg Med. 2017 Jun;18(4):770-774. doi: 10.5811/westjem.2017.3.31796. Epub 2017 Apr 19.
- Results publication: PubMed 28408076Church JT, Speck KE, Jarboe MD. Ultrasound-guided gastrostomy tube placement: A case series. J Pediatr Surg. 2017 Jul;52(7):1210-1214. doi: 10.1016/j.jpedsurg.2017.03.061. Epub 2017 Apr 2.
- Results publication: PubMed 22209831Chenaitia H, Brun PM, Querellou E, Leyral J, Bessereau J, Aime C, Bouaziz R, Georges A, Louis F; WINFOCUS (World Interactive Network Focused On Critical Ultrasound) Group France. Ultrasound to confirm gastric tube placement in prehospital management. Resuscitation. 2012 Apr;83(4):447-51. doi: 10.1016/j.resuscitation.2011.11.035. Epub 2011 Dec 29.
- Results publication: PubMed 25475801Correa JA, Fallon SC, Murphy KM, Victorian VA, Bisset GS, Vasudevan SA, Lopez ME, Brandt ML, Cass DL, Rodriguez JR, Wesson DE, Lee TC. Resource utilization after gastrostomy tube placement: defining areas of improvement for future quality improvement projects. J Pediatr Surg. 2014 Nov;49(11):1598-601. doi: 10.1016/j.jpedsurg.2014.06.015. Epub 2014 Aug 8.
- 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.
Rudy A Kink, MD study director
Le Bonheur Children's Hospital
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 in people with Gastrostomy Tube Site Complication and Gastrostomy Complications, run by University of Tennessee at 1 site in United States.
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 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 31 Oct 2023. 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 United States. 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?
Confirmation of gastrostomy tube placement (time frame: This procedure is brief (<5-10 minutes) and will be performed after gastrostomy tube replacement prior to the patient having the gold standard contrast injection performed before returning to their exam room. This should take no more than one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331873, which also lists 12 linked publications.
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 31 Oct 2023.