Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients

NCT04331873 | Completed

• 1 other identifier: 19-06455-XP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. A G-tube is a tube inserted through the abdomen and delivers nutrition directly into the stomach.

Conditions

Gastrostomy Tube Site Complication; Gastrostomy Complications

Keywords

gastrostomy; dislodged

Outcome Measures

Primary Outcomes (1)

• Confirmation of gastrostomy tube placement

  Ultrasound will be obtained in addition to contrast injection to determine gastrostomy tube placement

  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

Study Arms (1)

Ultrasound

EXPERIMENTAL

An ultrasound will be obtained to evaluate placement of the gastrostomy tube prior to obtaining the standard contrast injection

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

An ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal.

Also known as: US

Ultrasound

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Dislodged gastrostomy tube requiring contrast injection to confirm proper gastrostomy replacement

You may not qualify if:

• No ultrasound technician present in hospital
• Non-functioning ultrasound equipment (e.g. due to hardware issues)

Sponsors & Collaborators

• University of Tennessee: lead
• Le Bonheur Children's Hospital: collaborator

Study Sites (1)

LeBonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

Related Publications (12)

• 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.

  PMID: 27173980 BACKGROUND

• Myatt 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.

  PMID: 29346232 BACKGROUND

• Saavedra 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.

  PMID: 19864965 BACKGROUND

• Showalter 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.

  PMID: 22306396 BACKGROUND

• Tsujimoto 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.

  PMID: 28414415 BACKGROUND

• Wu 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.

  PMID: 18614327 BACKGROUND

• Zamora 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.

  PMID: 24909868 BACKGROUND

• Berman 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.

  PMID: 30229155 RESULT

• Bhambani 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.

  PMID: 28611900 RESULT

• Church 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.

  PMID: 28408076 RESULT

• Chenaitia 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.

  PMID: 22209831 RESULT

• Correa 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.

  PMID: 25475801 RESULT

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rudy A Kink, MD

  Le Bonheur Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 2, 2020
• Study Start: August 1, 2019
• Primary Completion: November 18, 2020
• Study Completion: February 1, 2021
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)