Epidural SpaceNCT02415998
Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients
An observational study of Epidural Space, run by Kenichi Ueda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Epidural Space
- What is being tested?
- TEE
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 23 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric population going under cardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hosptials and Clinics
Iowa City, Iowa, 52242
About this study
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).
Read the detailed description
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.
- Conditions
- Epidural Space
- Being tested
- TEE
- Keywords
- TEE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEEProcedure or surgery
Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
| Study group | Role | What they receive |
|---|---|---|
| TEE | Not described Receives: Procedure: TEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2012
- Primary completion23 Sep 2017
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Epidural SpaceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenichi Ueda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenichi Ueda, University of Iowa
- Investigators
- Kenichi Ueda, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415998
- Sponsor's protocol ID
- 201207769
- Status last verified
- May 2020
- First submitted
- 6 Apr 2015
- Last updated
- 28 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16720672Hassan SZ. Caudal anesthesia in infants. Anesth Analg. 1977 Sep-Oct;56(5):686-9. doi: 10.1213/00000539-197709000-00016.
PubMed 562094Valairucha 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.
PubMed 12060329Blanco 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.
PubMed 8669671Baidya 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.
PubMed 22345940Chawathe 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.
PubMed 14535905Tsui 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.
PubMed 12145046Tsui 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.
PubMed 10443599Rapp 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.
PubMed 16037140Tsui 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.
PubMed 16534352Roberts 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.
PubMed 15828997Owall 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.
PubMed 1543845
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02415998
- Acronym / sponsor ID
- 201207769
- Conditions
- Epidural Space
- Keywords
- TEE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kenichi UedaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 23 Sep 2017 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 28 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE | – | Procedure: TEE |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric population going under cardiac surgery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| TEEEpidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. | Procedure or surgery | TEE |
Primary outcome
Number of Participants With Successful Epidural Catheter Placement
Time frame: within one day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16720672Willschke 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.
- Results publication: PubMed 562094Hassan SZ. Caudal anesthesia in infants. Anesth Analg. 1977 Sep-Oct;56(5):686-9. doi: 10.1213/00000539-197709000-00016.
- Results publication: PubMed 12060329Valairucha 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.
- Results publication: PubMed 8669671Blanco 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.
- Results publication: PubMed 22345940Baidya 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.
- Results publication: PubMed 14535905Chawathe 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.
- Results publication: PubMed 12145046Tsui 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.
- Results publication: PubMed 10443599Tsui 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.
- Results publication: PubMed 16037140Rapp 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.
- Results publication: PubMed 16534352Tsui 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.
- Results publication: PubMed 15828997Roberts 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.
- Results publication: PubMed 1543845Owall 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.
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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.
Kenichi Ueda, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Space, run by Kenichi Ueda 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 1 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 28 May 2020. 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?
Yes. Results are posted in the registry (first posted 28 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Epidural Catheter Placement (time frame: within one day). 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 NCT02415998, 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 28 May 2020.