Cardiopulmonary BypassTP-EchoNCT01828411
Cerebral Perfusion Monitoring With Transpharyngeal Ultrasonography
An observational study of Cardiopulmonary Bypass, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU) as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass
- What is being tested?
- Transpharyngeal ultrasonography and Duplex sonography
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to Mar 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery at the University Hospital Bern.
Who may be able to join
- Signed informed consent
- Cardiopulmonary bypass procedure (normo-(group 1) or hypothermic (group 2))
Who cannot join
- Contraindication for transesophageal echocardiography
- Carotid artery stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion
This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU) as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump cardiovascular surgery.
In the first part of the study the investigators will investigate the feasibility of TPU for visualization of aortic arch branches including the innominate and the carotid arteries in twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation (cohort 1.). In the second part the investigators plan to adopt the investigators previous experiences on TPU to a selected population of twelve patients undergoing ascending aortic and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral perfusion stops or reductions due to surgical procedure, perfusion technique and their underlying disease (aortic dissection or aortic aneurysm).
The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive technique provides a simple and real-time adjunct to assess blood flow velocity in the extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery with its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.
Read the detailed description
Background
Cerebral hypo- or malperfusion during cardiovascular surgery can lead to grave consequences including transient cerebral ischemia or stroke impairing patient's daily life and affect surgical outcome. For this reason a multimodal neuromonitoring strategy using a variety of devices (evoked potentials, near-infrared spectroscopy, transcranial Doppler ultrasonography) with different technologies has been recommended by medical societies. These techniques have various limitations and cannot be used in all clinical situations. In contrast, transpharyngeal ultrasonography (TPU) represents a simple and readily available technique: the transesophageal echocardiography probe, routinely placed in most cardiac surgical patients for monitoring and assessment of surgical results, will be withdrawn into the upper esophagus making the visualization of supraaortic branches possible.
To date, there are several reports about imaging of aortic arch branches using TPU. The utility of this technique, however, for systematic cerebrovascular monitoring has not have been investigated so far.
Objective
The aim of this study is to investigate TPU as a cerebrovascular monitoring adjunct in two cohorts of on-pump cardiac surgery procedures. Clinical feasibility and diagnostic accuracy of antegrade carotid flow detection are compared to the established reference methods of Duplex sonography and transcranial Doppler ultrasound.
Methods
All patients receive anesthetic and surgical management according to institutional standards. Patient enrollment in the study occurs consecutively and unblinded for surgical procedure.
All patients receive TPU, Duplex sonography and transcranial Doppler examination after anesthesia induction preoperatively, during extracorporeal circulation and after weaning from cardiopulmonary bypass. In addition, the patients in cohort 2.(ascending aortic repair with DHCA) receive above mentioned noninvasive ultrasound / Doppler measurements also during the period of DHCA with and without antegrade cerebral perfusion.
Image acquisition and data extraction are conducted by different persons to avoid investigator-related bias.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Transpharyngeal ultrasonography, Duplex sonography
- Keywords
- Cardiac surgery, Echocardiography, Cerebral perfusion, Intraoperative period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpharyngeal ultrasonographyDevice
Transpharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries.
Duplex sonographyDevice
Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary bypass group | Patients requiring normothermic (or mild hypothermic) cardiopulmonary bypass. Receives: Device: Transpharyngeal ultrasonography; Device: Duplex sonography | |
| Hypothermic Cardiopulmonary Bypass Group | Patients requiring (deep) hypothermic cardiopulmonary bypass. Receives: Device: Transpharyngeal ultrasonography; Device: Duplex sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of cerebral flow velocity measurement
Cerebral blood flow velocity measurements will be performed using the pulsed wave Doppler technique. Doppler peak flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between the different Doppler techniques.
Measured: intraoperative phase, expected to be ca. 4 hours
Secondary outcomes (1)
clinical feasibility
Clinical feasibility will be assessed by analyzing the accuracy of data concordance, i.e. location of cerebral blood vessel, blood flow velocity and cerebral vessel area between the different Doppler techniques. Data will be plotted using Bland-Altman analysis.
Measured: intraoperative phase, expected to be ca. 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Balthasar Eberle, Prof., MD., Study chair, University Hospital Bern, Dep. of Anesthesiology and Pain therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828411
- Sponsor's protocol ID
- 056/10
- Acronym
- TP-Echo
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bevilacqua S, Romagnoli S, Ciappi F, Ridolfi N, Codecasa R, Rostagno C, Sorbara C. Transpharyngeal ultrasonography for cannulation of the internal jugular vein. Anesthesiology. 2005 Apr;102(4):873-4. doi: 10.1097/00000542-200504000-00038. No abstract available.
PubMed 15791132Shimizu H, Matayoshi T, Morita M, Ueda T, Yozu R. Total arch replacement under flow monitoring during selective cerebral perfusion using a single pump. Ann Thorac Surg. 2013 Jan;95(1):29-34. doi: 10.1016/j.athoracsur.2012.08.007. Epub 2012 Oct 4.
PubMed 23040825Orihashi K, Matsuura Y, Sueda T, Watari M, Okada K, Sugawara Y, Ishii O. Aortic arch branches are no longer a blind zone for transesophageal echocardiography: a new eye for aortic surgeons. J Thorac Cardiovasc Surg. 2000 Sep;120(3):466-72. doi: 10.1067/mtc.2000.108289.
PubMed 10962406Nanda NC, Miller AP, Nekkanti R, Aaluri S. Transpharyngeal echocardiographic imaging of the right and left carotid arteries. Echocardiography. 2001 Nov;18(8):711-6. doi: 10.1046/j.1540-8175.2001.00711.x.
PubMed 11801216Immer FF, Moser B, Krahenbuhl ES, Englberger L, Stalder M, Eckstein FS, Carrel T. Arterial access through the right subclavian artery in surgery of the aortic arch improves neurologic outcome and mid-term quality of life. Ann Thorac Surg. 2008 May;85(5):1614-8; discussion 1618. doi: 10.1016/j.athoracsur.2007.11.027.
PubMed 18442549
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT01828411
- Acronym / sponsor ID
- TP-Echo / 056/10
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Cardiac surgery, Echocardiography, Cerebral perfusion, Intraoperative period
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Apr 2013 (estimated)
- 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.
This prospective observational pilot study investigates transpharyngeal ultrasonography (TPU) as an additional neuromonitoring strategy to assess cerebral perfusion during on-pump cardiovascular surgery.
In the first part of the study the investigators will investigate the feasibility of TPU for visualization of aortic arch branches including the innominate and the carotid arteries in twenty patients undergoing coronary artery bypass grafting with extracorporeal circulation (cohort 1.). In the second part the investigators plan to adopt the investigators previous experiences on TPU to a selected population of twelve patients undergoing ascending aortic and/or arch repair in deep hypothermic circulatory arrest (DHCA, cohort 2.). In contrast to cohort 1., patients in cohort 2. are exposed intraoperatively to intermittent cerebral perfusion stops or reductions due to surgical procedure, perfusion technique and their underlying disease (aortic dissection or aortic aneurysm).
The investigators hypothesize that cerebral perfusion monitoring using TPU as a non-invasive technique provides a simple and real-time adjunct to assess blood flow velocity in the extracranial cephalic vessels with Doppler ultrasound. Especially in aortic arch surgery with its inherent risk of cerebral hypoperfusion TPU might be a valuable adjunct to routine.
Detailed description
Background
Cerebral hypo- or malperfusion during cardiovascular surgery can lead to grave consequences including transient cerebral ischemia or stroke impairing patient's daily life and affect surgical outcome. For this reason a multimodal neuromonitoring strategy using a variety of devices (evoked potentials, near-infrared spectroscopy, transcranial Doppler ultrasonography) with different technologies has been recommended by medical societies. These techniques have various limitations and cannot be used in all clinical situations. In contrast, transpharyngeal ultrasonography (TPU) represents a simple and readily available technique: the transesophageal echocardiography probe, routinely placed in most cardiac surgical patients for monitoring and assessment of surgical results, will be withdrawn into the upper esophagus making the visualization of supraaortic branches possible.
To date, there are several reports about imaging of aortic arch branches using TPU. The utility of this technique, however, for systematic cerebrovascular monitoring has not have been investigated so far.
Objective
The aim of this study is to investigate TPU as a cerebrovascular monitoring adjunct in two cohorts of on-pump cardiac surgery procedures. Clinical feasibility and diagnostic accuracy of antegrade carotid flow detection are compared to the established reference methods of Duplex sonography and transcranial Doppler ultrasound.
Methods
All patients receive anesthetic and surgical management according to institutional standards. Patient enrollment in the study occurs consecutively and unblinded for surgical procedure.
All patients receive TPU, Duplex sonography and transcranial Doppler examination after anesthesia induction preoperatively, during extracorporeal circulation and after weaning from cardiopulmonary bypass. In addition, the patients in cohort 2.(ascending aortic repair with DHCA) receive above mentioned noninvasive ultrasound / Doppler measurements also during the period of DHCA with and without antegrade cerebral perfusion.
Image acquisition and data extraction are conducted by different persons to avoid investigator-related bias.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary bypass group | – | Device: Transpharyngeal ultrasonography, Device: Duplex sonographyPatients requiring normothermic (or mild hypothermic) cardiopulmonary bypass. |
| Hypothermic Cardiopulmonary Bypass Group | – | Device: Transpharyngeal ultrasonography, Device: Duplex sonographyPatients requiring (deep) hypothermic cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery at the University Hospital Bern.
Key inclusion criteria (2 listed)
- Signed informed consent
- Cardiopulmonary bypass procedure (normo-(group 1) or hypothermic (group 2))
Key exclusion criteria (2 listed)
- Contraindication for transesophageal echocardiography
- Carotid artery stenosis
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 |
|---|---|---|
| Transpharyngeal ultrasonographyTranspharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries. | Device | Cardiopulmonary bypass group, Hypothermic Cardiopulmonary Bypass Group |
| Duplex sonographyAssessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting. | Device | Cardiopulmonary bypass group, Hypothermic Cardiopulmonary Bypass Group |
Primary outcome
accuracy of cerebral flow velocity measurement
Time frame: intraoperative phase, expected to be ca. 4 hours
Cerebral blood flow velocity measurements will be performed using the pulsed wave Doppler technique. Doppler peak flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between the different Doppler techniques.
1 secondary outcome
clinical feasibility
Time frame: intraoperative phase, expected to be ca. 4 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 15791132Bevilacqua S, Romagnoli S, Ciappi F, Ridolfi N, Codecasa R, Rostagno C, Sorbara C. Transpharyngeal ultrasonography for cannulation of the internal jugular vein. Anesthesiology. 2005 Apr;102(4):873-4. doi: 10.1097/00000542-200504000-00038. No abstract available.
- Background: PubMed 23040825Shimizu H, Matayoshi T, Morita M, Ueda T, Yozu R. Total arch replacement under flow monitoring during selective cerebral perfusion using a single pump. Ann Thorac Surg. 2013 Jan;95(1):29-34. doi: 10.1016/j.athoracsur.2012.08.007. Epub 2012 Oct 4.
- Background: PubMed 10962406Orihashi K, Matsuura Y, Sueda T, Watari M, Okada K, Sugawara Y, Ishii O. Aortic arch branches are no longer a blind zone for transesophageal echocardiography: a new eye for aortic surgeons. J Thorac Cardiovasc Surg. 2000 Sep;120(3):466-72. doi: 10.1067/mtc.2000.108289.
- Background: PubMed 11801216Nanda NC, Miller AP, Nekkanti R, Aaluri S. Transpharyngeal echocardiographic imaging of the right and left carotid arteries. Echocardiography. 2001 Nov;18(8):711-6. doi: 10.1046/j.1540-8175.2001.00711.x.
- Background: PubMed 18442549Immer FF, Moser B, Krahenbuhl ES, Englberger L, Stalder M, Eckstein FS, Carrel T. Arterial access through the right subclavian artery in surgery of the aortic arch improves neurologic outcome and mid-term quality of life. Ann Thorac Surg. 2008 May;85(5):1614-8; discussion 1618. doi: 10.1016/j.athoracsur.2007.11.027.
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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.
Balthasar Eberle, Prof., MD. study chair
University Hospital Bern, Dep. of Anesthesiology and Pain therapy
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 Cardiopulmonary Bypass, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 Switzerland. 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 was stopped early. Results are not available in the source record.
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?
accuracy of cerebral flow velocity measurement (time frame: intraoperative phase, expected to be ca. 4 hours). 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 NCT01828411, which also lists 5 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 5 Apr 2018.