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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).
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.
The primary outcome is to determine the success rate achieved using TEE guidance to thread an epidural catheter to a targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position.
The secondary outcomes include analysis of catheter tip position within the epidural space as anterior, lateral or inferior to the spinal cord. Further, efficacy of the catheter will be determined using the following criteria from previous studies: Hemodynamic response at skin incision analyzed by heart rate and systemic blood pressure changes using the no change in HR or BP or changes < 20% from baseline were considered "sufficient block" to surgical stimulation, while HR or BP changes > 20% from baseline were considered "not sufficient block" to surgical stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEE | Procedure | Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric population going under cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Kenichi Ueda, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hosptials and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16720672 | Result | 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. | |
| 562094 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | TEE Guided Epidural Catheter Placement | TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TEE Guided Epidural Cather Placement | TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | within one day |
|
|
one day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEE Guided Epidural Cather Placement | TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenichi Ueda | University of Iowa | 319-356-2633 | kenichi-ueda@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2012 | Feb 21, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2012 | May 20, 2020 | ICF_001.pdf |
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| Hassan SZ. Caudal anesthesia in infants. Anesth Analg. 1977 Sep-Oct;56(5):686-9. doi: 10.1213/00000539-197709000-00016. |
| 12060329 | 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. |
| 8669671 | 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. |
| 22345940 | 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. |
| 14535905 | 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. |
| 12145046 | 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. |
| 10443599 | 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. |
| 16037140 | 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. |
| 16534352 | 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. |
| 15828997 | 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. |
| 1543845 | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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