Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients

NCT02415998 | Completed Results

• 1 other identifier: 201207769
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used to successfully guide an epidural catheter to a targeted thoracic level in pediatric patients. The catheter will be placed in the epidural space under real-time TEE imaging and assistance by a trained TEE operator (this could include an anesthesiologist or cardiologist).

Conditions

Epidural Space

Keywords

TEE

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Epidural Catheter Placement

  The success rate achieved using TEE guidance to thread an epidural catheter to within one targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position.

  within one day

Study Arms (1)

TEE

Procedure: TEE

Interventions

TEE PROCEDURE

Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.

TEE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric population going under cardiac surgery

You may qualify if:

• pediatric patients scheduled to undergo cardiothoracic surgery or interventional cardiology diagnostic procedures under general anesthesia. All subjects will also be scheduled to undergo post-operative chest x-ray as a routine part of their clinical care, so no additional exposure to ionizing radiation will occur due to this study.

You may not qualify if:

• patients with known esophageal abnormalities, lesions or disease that would disqualify the patient for the use of TEE as standard procedure. We will further exclude any patients that are solely undergoing TEE diagnostic procedures and only include patients that are already scheduled to undergo procedures where TEE is used as part of routine surgical preparation.

Sponsors & Collaborators

• Kenichi Ueda: lead

Study Sites (1)

University of Iowa Hosptials and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (12)

• Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Sitzwohl C, Kettner S, Kapral S. Epidural catheter placement in children: comparing a novel approach using ultrasound guidance and a standard loss-of-resistance technique. Br J Anaesth. 2006 Aug;97(2):200-7. doi: 10.1093/bja/ael121. Epub 2006 May 23.

  PMID: 16720672 RESULT

• Hassan SZ. Caudal anesthesia in infants. Anesth Analg. 1977 Sep-Oct;56(5):686-9. doi: 10.1213/00000539-197709000-00016.

  PMID: 562094 RESULT

• Valairucha S, Seefelder C, Houck CS. Thoracic epidural catheters placed by the caudal route in infants: the importance of radiographic confirmation. Paediatr Anaesth. 2002 Jun;12(5):424-8. doi: 10.1046/j.1460-9592.2002.00884.x.

  PMID: 12060329 RESULT

• Blanco D, Llamazares J, Rincon R, Ortiz M, Vidal F. Thoracic epidural anesthesia via the lumbar approach in infants and children. Anesthesiology. 1996 Jun;84(6):1312-6. doi: 10.1097/00000542-199606000-00006.

  PMID: 8669671 RESULT

• Baidya DK, Pawar DK, Dehran M, Gupta AK. Advancement of epidural catheter from lumbar to thoracic space in children: Comparison between 18G and 23G catheters. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):21-7. doi: 10.4103/0970-9185.92429.

  PMID: 22345940 RESULT

• Chawathe MS, Jones RM, Gildersleve CD, Harrison SK, Morris SJ, Eickmann C. Detection of epidural catheters with ultrasound in children. Paediatr Anaesth. 2003 Oct;13(8):681-4. doi: 10.1046/j.1460-9592.2003.01151.x.

  PMID: 14535905 RESULT

• Tsui BC, Seal R, Koller J. Thoracic epidural catheter placement via the caudal approach in infants by using electrocardiographic guidance. Anesth Analg. 2002 Aug;95(2):326-30, table of contents. doi: 10.1097/00000539-200208000-00016.

  PMID: 12145046 RESULT

• Tsui BC, Tarkkila P, Gupta S, Kearney R. Confirmation of caudal needle placement using nerve stimulation. Anesthesiology. 1999 Aug;91(2):374-8. doi: 10.1097/00000542-199908000-00010.

  PMID: 10443599 RESULT

• Rapp HJ, Folger A, Grau T. Ultrasound-guided epidural catheter insertion in children. Anesth Analg. 2005 Aug;101(2):333-339. doi: 10.1213/01.ANE.0000156579.11254.D1.

  PMID: 16037140 RESULT

• Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.

  PMID: 16534352 RESULT

• Roberts SA, Galvez I. Ultrasound assessment of caudal catheter position in infants. Paediatr Anaesth. 2005 May;15(5):429-32. doi: 10.1111/j.1460-9592.2004.01512.x.

  PMID: 15828997 RESULT

• Owall A, Stahl L, Settergren G. Incidence of sore throat and patient complaints after intraoperative transesophageal echocardiography during cardiac surgery. J Cardiothorac Vasc Anesth. 1992 Feb;6(1):15-6. doi: 10.1016/1053-0770(91)90037-t.

  PMID: 1543845 RESULT

Results Point of Contact

• Title: Kenichi Ueda
• Organization: University of Iowa

kenichi-ueda@uiowa.edu

319-356-2633

Study Officials

• Kenichi Ueda, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 14, 2015
• Study Start: July 1, 2012
• Primary Completion: September 23, 2017
• Study Completion: September 23, 2017
• Last Updated: May 28, 2020
• Results First Posted: May 28, 2020

Record last verified: 2020-05

Locations

US (1)