Central Venous CatheterizationNCT05409768
Comparison of Two Approach in Ultrasound Guided Central Venous Catheterizations
A study testing Short axis out of plane and Anteroposterior short axis in plane in people with Central Venous Catheterization, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
Ultrasound guidance in central venous catheterization has become the standard for clinical practice. Many approaches have been described in ultrasound guided catheterization procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- Short axis out of plane and Anteroposterior short axis in plane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are planned a central venous catheter placement
Who cannot join
- Morbid obese patients (body mass index> 40)
- People with severe coagulopathy
- Severe deformity at the neck
- Skin deformity or infection at catheterization site
- Congenital anomalies of central veins
- Emergency operations
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Abant İzzet Baysal Education and Training Hospital
Bolu, Merkez
- Completed
Bolu Abant İzzet Baysal University Faculty of Medicine
Bolu, 14030
About this study
Official title: Comparison of Short Axis Out of Plane Method and Anteroposterior Short Axis in Plane Method in Ultrasound-guided Central Venous Catheterizations
Ultrasound guidance in central venous catheterization has become the standard for clinical practice. Many approaches have been described in ultrasound guided catheterization procedures. The aim of this study is to compare the classical short axis out of plane (SAX-OOP) approach and the new anteroposterior short axis in plane (APSAX-IP approach in central jugular venous catheterization. The study was planned as prospective randomized and controlled. One hundred patients were planned to be included in this study.
Patients will be divided into two groups: Central jugular vein catheterization will be performed with the short axis out of plane group (ultrasound transducer will be positioned classically from medial to lateral in the neck) and anteroposterior short axis in plane group (ultrasound transducer will be positioned laterally from anterior to posterior on the neck). The two groups will be compared in terms of number of puncture attempts, duration of the procedure, ultrasound scan time before the procedure, number of needle redirection, overall success rate, complications, ease of catheterization and ultrasound visibility.
Read the detailed description
Central venous catheterization is a method frequently used in intensive care patients and patients to be operated. With classical methods, this central venous vascular access procedure in the landmark method can be performed or it can be successfully performed under ultrasound guidance.
Ultrasound-guided central venous catheterization is a safer and recommended approach. During venous catheterization with ultrasound the vein and its neighborhood can be easily visualized and it can be followed while the needle is directed to the target in vein puncture. Undesirable complications (hematoma, pneumothorax, arterial puncture) also decrease with the decrease in the number of punctures under ultrasound guidance. Ultrasound guided central catheterization which facilitates safer and faster procedures constitutes an important area for patient care. With the development of technology and the increase in accessibility it constitutes an important and useful area in the interventions made with ultrasound. The internal jugular vein is a frequently chosen central venous structure.
Many ultrasound-guided imaging and intervention methods have been described for catheterization of the internal jugular vein with the Seldinger method. These are described as longitudinal (long axis), transverse (short axis) and oblique methods for imaging and probe position. The image taken with the position of the needle relative to the ultrasound probe is described as in plane and out of plane.
Each method may have advantages over each other and can be preferred according to the patient's condition and the experience of the practitioner. Successful and safe catheterizations can be performed in the internal jugular vein with the short axis out-of-plane (SAX-OOP) method which is especially used in adults . Short axis out of plane is a successful method that can almost be called a classic that comes to mind first. Compared to other needle imaging methods out of plane tracking of the needle (as a point) seems to be a disadvantage in the user's imaging compared to the in-plane tracking method. Of course, it is easier and faster to capture the short axis when imaging the venous structure as long axis or short axis with ultrasound.
The " Anteroposterior short axis in plane" (APSAX-IP) technique is first reported by Aithal G. et al. in 2019. The use of both short axis and in-plane approaches has been described.The difference of the anteroposterior short axis in plane (APSAX-IP ) technique from the classical short axis out of plane (SAX-OOP) technique is that the location of the ultrasound is lateral to the neck, the needle is about 2-3 cm away from the ultrasound, the entry area from the skin, the needle is advanced subcutaneously in the anteroposterior direction, not medially, and the needle is not as a point in ultrasound that can be viewed longitudinally. It is thought that the APSAX-IP method has advantages such as easier follow-up of the needle, easier monitoring of the progression of the needle without damaging the posterior wall by seeing a large anterior posterior diameter of the vessel. It is stated that the APSAX-IP method will be more ergonomic in patients with short neck anatomy, obese and pediatric patients due to the location of the ultrasound probe. One method may be preferred over the other in patients. Although the definition of the method has been made, it has not been compared with any catheterization method. The aim of our study is to compare the classical SAX-OOP method and the newly defined APSAX-IP method in terms of difficulty, needle puncture time, needle procedure time and complications.
- Conditions
- Central Venous Catheterization
- Being tested
- Short axis out of plane, Anteroposterior short axis in plane
- Keywords
- Ultrasound Guided Short, Central Venous Catheterization, Short Axis in-plane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short axis out of planeProcedure or surgery
Also called Ultrasound guided central venous catheterization with short axis out of plane approach
A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance short axis visualisation out of plane approaches.
Anteroposterior short axis in planeProcedure or surgery
Also called Ultrasound guided central venous catheterization with anteroposterior short axis in plane approach
A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance anteroposterior short axis visualisation in plane approaches.
| Study group | Role | What they receive |
|---|---|---|
| Short axis, out of plane approach | Experimental | A linear ultrasound probe will be utilized to place the central catheter into the jugular vein with a short axis out of the plane method Receives: Procedure: Short axis out of plane |
| Short axis, anteroposterior in plane approach | Experimental | A linear ultrasound probe will be utilized to place the central catheter into the jugular vein with an anteroposterior short axis in-plane method Receives: Procedure: Anteroposterior short axis in plane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture attempts
Number of needle insertions to the catheterization region for placing a catheter
Measured: From the 1st second through withdrawal of the needle, up to 3 minutes
Cannulation procedural time
Duration of the whole cannulation procedure
Measured: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes
Catheterization procedural time
Duration of the whole catheterization procedure
Measured: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes
Number of needle redirections
Redirections of the needle towards the vessel
Measured: During the whole cannulation procedure
Success rate
Correct placement of the catheter over the guidewire after central vein puncture
Measured: Through catheterizations completion, an average of 4 months
Success rate at first attempt
Success rate at first attempt of the procedures in each group
Measured: Through study completion, an average of 4 months
Complications
Rate of complications that occur during catheterization procedure
Measured: Through study completion, an average of 4 months ]
Secondary outcomes (5)
Vessel visualization
Visualization of the vessels in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minutes
Needle visualization
Visualization of the needle in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minutes
Guide-wire visualization
Visualization of the guide-wire in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minute
Ease of the catheterization process
A subjective score assigned by the operator on a scale with a minimum value of 0 and maximum value of 10. Higher scores mean a better outcome
Measured: Throughout the procedure; up to 3 minutes
Ultrasound time
The duration of pre-procedural ultrasound scanning
Measured: Throughout the pre-procedural ultrasonography; up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Aug 2022
- Primary completion10 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Central Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Ital, Abant Izzet Baysal University
- Investigators
- Ilker Ital, MD, Principal investigator, Bolu Abant Izzet Baysal University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409768
- Sponsor's protocol ID
- AIBU-TF-AR-II-001
- Status last verified
- Feb 2023
- First submitted
- 8 May 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aithal G, Muthuswamy G, Latif Z, Bhaskaran V, Haji Sani HS, Shindhe S, Manap NBA, Vadaje KS, Dato Paduka Buntar WS, Daiwajna RG. An Alternate In-Plane Technique of Ultrasound-Guided Internal Jugular Vein Cannulation. J Emerg Med. 2019 Dec;57(6):852-858. doi: 10.1016/j.jemermed.2019.08.029. Epub 2019 Oct 18.
PubMed 31635927Ince I, Ari MA, Sulak MM, Aksoy M. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance]. Braz J Anesthesiol. 2018 May-Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23.
PubMed 29478705Aydin T, Balaban O, Turgut M, Tokur ME, Musmul A. A Novel Method for Ultrasound-Guided Central Catheter Placement-Supraclavicular Brachiocephalic Vein Catheterization Versus Jugular Catheterization: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2022 Apr;36(4):998-1006. doi: 10.1053/j.jvca.2021.06.010. Epub 2021 Jun 12.
PubMed 34247928Rossi UG, Rigamonti P, Ticha V, Zoffoli E, Giordano A, Gallieni M, Cariati M. Percutaneous ultrasound-guided central venous catheters: the lateral in-plane technique for internal jugular vein access. J Vasc Access. 2014 Jan-Feb;15(1):56-60. doi: 10.5301/jva.5000177. Epub 2013 Oct 7.
PubMed 24101418Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Special articles: guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society Of Cardiovascular Anesthesiologists. Anesth Analg. 2012 Jan;114(1):46-72. doi: 10.1213/ANE.0b013e3182407cd8. Epub 2011 Nov 29. No abstract available.
PubMed 22127816
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short Axis Out of Plane Method and Anteroposterior Short Axis in Plane Method in Ultrasound-guided Central Venous Catheterizations
- ClinicalTrials.gov ID
- NCT05409768
- Acronym / sponsor ID
- AIBU-TF-AR-II-001
- Conditions
- Central Venous Catheterization
- Keywords
- Ultrasound Guided Short, Central Venous Catheterization, Short Axis in-plane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- 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.
Ultrasound guidance in central venous catheterization has become the standard for clinical practice. Many approaches have been described in ultrasound guided catheterization procedures. The aim of this study is to compare the classical short axis out of plane (SAX-OOP) approach and the new anteroposterior short axis in plane (APSAX-IP approach in central jugular venous catheterization. The study was planned as prospective randomized and controlled. One hundred patients were planned to be included in this study.
Patients will be divided into two groups: Central jugular vein catheterization will be performed with the short axis out of plane group (ultrasound transducer will be positioned classically from medial to lateral in the neck) and anteroposterior short axis in plane group (ultrasound transducer will be positioned laterally from anterior to posterior on the neck). The two groups will be compared in terms of number of puncture attempts, duration of the procedure, ultrasound scan time before the procedure, number of needle redirection, overall success rate, complications, ease of catheterization and ultrasound visibility.
Detailed description
Central venous catheterization is a method frequently used in intensive care patients and patients to be operated. With classical methods, this central venous vascular access procedure in the landmark method can be performed or it can be successfully performed under ultrasound guidance.
Ultrasound-guided central venous catheterization is a safer and recommended approach. During venous catheterization with ultrasound the vein and its neighborhood can be easily visualized and it can be followed while the needle is directed to the target in vein puncture. Undesirable complications (hematoma, pneumothorax, arterial puncture) also decrease with the decrease in the number of punctures under ultrasound guidance. Ultrasound guided central catheterization which facilitates safer and faster procedures constitutes an important area for patient care. With the development of technology and the increase in accessibility it constitutes an important and useful area in the interventions made with ultrasound. The internal jugular vein is a frequently chosen central venous structure.
Many ultrasound-guided imaging and intervention methods have been described for catheterization of the internal jugular vein with the Seldinger method. These are described as longitudinal (long axis), transverse (short axis) and oblique methods for imaging and probe position. The image taken with the position of the needle relative to the ultrasound probe is described as in plane and out of plane.
Each method may have advantages over each other and can be preferred according to the patient's condition and the experience of the practitioner. Successful and safe catheterizations can be performed in the internal jugular vein with the short axis out-of-plane (SAX-OOP) method which is especially used in adults . Short axis out of plane is a successful method that can almost be called a classic that comes to mind first. Compared to other needle imaging methods out of plane tracking of the needle (as a point) seems to be a disadvantage in the user's imaging compared to the in-plane tracking method. Of course, it is easier and faster to capture the short axis when imaging the venous structure as long axis or short axis with ultrasound.
The " Anteroposterior short axis in plane" (APSAX-IP) technique is first reported by Aithal G. et al. in 2019. The use of both short axis and in-plane approaches has been described.The difference of the anteroposterior short axis in plane (APSAX-IP ) technique from the classical short axis out of plane (SAX-OOP) technique is that the location of the ultrasound is lateral to the neck, the needle is about 2-3 cm away from the ultrasound, the entry area from the skin, the needle is advanced subcutaneously in the anteroposterior direction, not medially, and the needle is not as a point in ultrasound that can be viewed longitudinally. It is thought that the APSAX-IP method has advantages such as easier follow-up of the needle, easier monitoring of the progression of the needle without damaging the posterior wall by seeing a large anterior posterior diameter of the vessel. It is stated that the APSAX-IP method will be more ergonomic in patients with short neck anatomy, obese and pediatric patients due to the location of the ultrasound probe. One method may be preferred over the other in patients. Although the definition of the method has been made, it has not been compared with any catheterization method. The aim of our study is to compare the classical SAX-OOP method and the newly defined APSAX-IP method in terms of difficulty, needle puncture time, needle procedure time and complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short axis, out of plane approach | Experimental | Procedure: Short axis out of planeA linear ultrasound probe will be utilized to place the central catheter into the jugular vein with a short axis out of the plane method |
| Short axis, anteroposterior in plane approach | Experimental | Procedure: Anteroposterior short axis in planeA linear ultrasound probe will be utilized to place the central catheter into the jugular vein with an anteroposterior short axis in-plane method |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that are planned a central venous catheter placement
Key exclusion criteria (6 listed)
- Morbid obese patients (body mass index> 40)
- People with severe coagulopathy
- Severe deformity at the neck
- Skin deformity or infection at catheterization site
- Congenital anomalies of central veins
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 |
|---|---|---|
| Short axis out of planeAlso: Ultrasound guided central venous catheterization with short axis out of plane approachA standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance short axis visualisation out of plane approaches. | Procedure or surgery | Short axis, out of plane approach |
| Anteroposterior short axis in planeAlso: Ultrasound guided central venous catheterization with anteroposterior short axis in plane approachA standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance anteroposterior short axis visualisation in plane approaches. | Procedure or surgery | Short axis, anteroposterior in plane approach |
Primary outcome
Number of puncture attempts
Time frame: From the 1st second through withdrawal of the needle, up to 3 minutes
Number of needle insertions to the catheterization region for placing a catheter
Cannulation procedural time
Time frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes
Duration of the whole cannulation procedure
Catheterization procedural time
Time frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes
Duration of the whole catheterization procedure
Number of needle redirections
Time frame: During the whole cannulation procedure
Redirections of the needle towards the vessel
Success rate
Time frame: Through catheterizations completion, an average of 4 months
Correct placement of the catheter over the guidewire after central vein puncture
Success rate at first attempt
Time frame: Through study completion, an average of 4 months
Success rate at first attempt of the procedures in each group
Complications
Time frame: Through study completion, an average of 4 months ]
Rate of complications that occur during catheterization procedure
5 secondary outcomes
Vessel visualization
Time frame: Throughout the procedure; up to 3 minutes
Needle visualization
Time frame: Throughout the procedure; up to 3 minutes
Guide-wire visualization
Time frame: Throughout the procedure; up to 3 minute
Ease of the catheterization process
Time frame: Throughout the procedure; up to 3 minutes
Ultrasound time
Time frame: Throughout the pre-procedural ultrasonography; up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 31635927Aithal G, Muthuswamy G, Latif Z, Bhaskaran V, Haji Sani HS, Shindhe S, Manap NBA, Vadaje KS, Dato Paduka Buntar WS, Daiwajna RG. An Alternate In-Plane Technique of Ultrasound-Guided Internal Jugular Vein Cannulation. J Emerg Med. 2019 Dec;57(6):852-858. doi: 10.1016/j.jemermed.2019.08.029. Epub 2019 Oct 18.
- Background: PubMed 29478705Ince I, Ari MA, Sulak MM, Aksoy M. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance]. Braz J Anesthesiol. 2018 May-Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23.
- Background: PubMed 34247928Aydin T, Balaban O, Turgut M, Tokur ME, Musmul A. A Novel Method for Ultrasound-Guided Central Catheter Placement-Supraclavicular Brachiocephalic Vein Catheterization Versus Jugular Catheterization: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2022 Apr;36(4):998-1006. doi: 10.1053/j.jvca.2021.06.010. Epub 2021 Jun 12.
- Background: PubMed 24101418Rossi UG, Rigamonti P, Ticha V, Zoffoli E, Giordano A, Gallieni M, Cariati M. Percutaneous ultrasound-guided central venous catheters: the lateral in-plane technique for internal jugular vein access. J Vasc Access. 2014 Jan-Feb;15(1):56-60. doi: 10.5301/jva.5000177. Epub 2013 Oct 7.
- Background: PubMed 22127816Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Special articles: guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society Of Cardiovascular Anesthesiologists. Anesth Analg. 2012 Jan;114(1):46-72. doi: 10.1213/ANE.0b013e3182407cd8. Epub 2011 Nov 29. No abstract available.
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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.
Ilker Ital, MD principal investigator
Bolu Abant Izzet Baysal University Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short axis out of plane and Anteroposterior short axis in plane in people with Central Venous Catheterization, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
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 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilker Ital, MD ((0374) 253 46 56, ilkerital@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture attempts (time frame: From the 1st second through withdrawal of the needle, up to 3 minutes). The study lists 7 primary outcomes in all. 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 NCT05409768, 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 15 Feb 2023.