Arterio-venous FistulaNCT04978155
Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access
An observational study of Arterio-venous Fistula, run by University Paul Sabatier of Toulouse at 1 site in France.
Trial summary
Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula
- What is being tested?
- Duplex ultrasound performed by the surgeon after locoregional anesthesia
- How many people
- 193 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jul 2021
- 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: All the patients who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE during the year 2020.
Who may be able to join
- Native AVF access
- During the year 2020
- Preoperative mapping during the consultation
- Loco-regional anesthesia
Who cannot join
- Redo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient).
On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small.
The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.
Read the detailed description
The investigators conducted a prospective study in the year 2020 during which all the patients (n=90) had an AVF creation with preoperative venous identification by the surgeon at university hospital of TOULOUSE (France)(echo group).
All the patients gave their consent, and the database was anonymised upon completion.
All patients were seen in a preoperative consultation with venous mapping carried out by a physician specialised in the use of Doppler ultrasonography. Following this consultation, a type of fistula was programmed in accordance with the Silva criteria (notably a vein with a diameter of over 2.5mm and an artery of 2mm). On the day of the operation, loco-regional anaesthesia was performed under sonographic guidance according to the previous description . The decision of the block approach and the choice of local aesthetic agent was left to the discretion of the anaesthesiologist.
The surgeon carried out an ultrasound and modification of the type of AVF was then made if the Silva criteria differed from those described during initial consultation. The modification could be a more distal creation, a more proximal creation, a change of vein or a change of artery.
The investigators succeeded to create more distal AVF when the vein had a diameter of over 2.5mm after LRA. Furthermore, the investigators reassembled the AVF when the vein appeared too small or residual (for example, following the attachment of an infusion having occurred between mapping and the surgery).
The same team of 4 surgeons participated in the creation of the AVF for both the echo group and the control group.
All patients were given a preoperative assessment of their heart function and cardiovascular risk factors (HTA, diabetes, smoking, dyslipidaemia). Prior strokes and coronary diseases were also registered as well as the patients' BMI and American society of anesthesiology score.
The definition of the good development of the haemodialysis access is based on the National Kidney Foundation's criteria: Blood flow>600ml, diameter over 6mm and lower depth of 6mm. On the other hand, permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access. Assisted primary permeability ends at the time of the first occlusion episode. Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure.
The first postoperative consultation took place at around the 6th week after the creation which is the normal time necessary for the smooth development of an AVF .
The investigators compared all these results with our control group which consists of all the patients who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation. Demographic data was similarly compiled and all the evaluation criteria compared
- Conditions
- Arterio-venous Fistula
- Being tested
- Duplex ultrasound performed by the surgeon after locoregional anesthesia
- Keywords
- Arterio-veinous fistula access, preoperative Doppler ultrasound, maturation access
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex ultrasound performed by the surgeon after locoregional anesthesiaDiagnostic test
Just after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation. So the plan can be changed such as more distal, more proximal creation, changing vein or artery target.
| Study group | Role | What they receive |
|---|---|---|
| Echo group | All the patients (n=90) who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE (echo group). Receives: Diagnostic Test: Duplex ultrasound performed by the surgeon after locoregional anesthesia | |
| Control | All the patients (n=93) who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of the AVF at the time of the postoperative
An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow>600ml, diameter over 6mm and lower depth of 6mm
Measured: 6 weeks
Secondary outcomes (2)
The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed
Measured: During the surgery
Primary, assisted primary and secondary permeability of our accesses
permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access. Assisted primary permeability ends at the time of the first occlusion episode. Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2020
- Primary completion1 Feb 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978155
- Sponsor's protocol ID
- ECHO FAV
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hostalrich A, Boisroux T, Segal J, Lebas B, Ricco JB, Chaufour X. Assessment of Duplex Ultrasound Carried Out by the Vascular Surgeon After Locoregional Anesthesia for Preferred Arteriovenous Fistula Access. Ann Vasc Surg. 2022 Jul;83:117-123. doi: 10.1016/j.avsg.2021.11.014. Epub 2021 Dec 20.
PubMed 34942337
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access
- ClinicalTrials.gov ID
- NCT04978155
- Acronym / sponsor ID
- ECHO FAV
- Conditions
- Arterio-venous Fistula
- Keywords
- Arterio-veinous fistula access, preoperative Doppler ultrasound, maturation access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 27 Jul 2021 (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.
Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient).
On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small.
The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.
Detailed description
The investigators conducted a prospective study in the year 2020 during which all the patients (n=90) had an AVF creation with preoperative venous identification by the surgeon at university hospital of TOULOUSE (France)(echo group).
All the patients gave their consent, and the database was anonymised upon completion.
All patients were seen in a preoperative consultation with venous mapping carried out by a physician specialised in the use of Doppler ultrasonography. Following this consultation, a type of fistula was programmed in accordance with the Silva criteria (notably a vein with a diameter of over 2.5mm and an artery of 2mm). On the day of the operation, loco-regional anaesthesia was performed under sonographic guidance according to the previous description . The decision of the block approach and the choice of local aesthetic agent was left to the discretion of the anaesthesiologist.
The surgeon carried out an ultrasound and modification of the type of AVF was then made if the Silva criteria differed from those described during initial consultation. The modification could be a more distal creation, a more proximal creation, a change of vein or a change of artery.
The investigators succeeded to create more distal AVF when the vein had a diameter of over 2.5mm after LRA. Furthermore, the investigators reassembled the AVF when the vein appeared too small or residual (for example, following the attachment of an infusion having occurred between mapping and the surgery).
The same team of 4 surgeons participated in the creation of the AVF for both the echo group and the control group.
All patients were given a preoperative assessment of their heart function and cardiovascular risk factors (HTA, diabetes, smoking, dyslipidaemia). Prior strokes and coronary diseases were also registered as well as the patients' BMI and American society of anesthesiology score.
The definition of the good development of the haemodialysis access is based on the National Kidney Foundation's criteria: Blood flow>600ml, diameter over 6mm and lower depth of 6mm. On the other hand, permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access. Assisted primary permeability ends at the time of the first occlusion episode. Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure.
The first postoperative consultation took place at around the 6th week after the creation which is the normal time necessary for the smooth development of an AVF .
The investigators compared all these results with our control group which consists of all the patients who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation. Demographic data was similarly compiled and all the evaluation criteria compared
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo group | – | Diagnostic Test: Duplex ultrasound performed by the surgeon after locoregional anesthesiaAll the patients (n=90) who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE (echo group). |
| Control | – | –All the patients (n=93) who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE during the year 2020.
Key inclusion criteria (4 listed)
- Native AVF access
- During the year 2020
- Preoperative mapping during the consultation
- Loco-regional anesthesia
Key exclusion criteria (1 listed)
- Redo surgery
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 |
|---|---|---|
| Duplex ultrasound performed by the surgeon after locoregional anesthesiaJust after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation. So the plan can be changed such as more distal, more proximal creation, changing vein or artery target. | Diagnostic test | Echo group |
Primary outcome
Functionality of the AVF at the time of the postoperative
Time frame: 6 weeks
An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow>600ml, diameter over 6mm and lower depth of 6mm
2 secondary outcomes
The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed
Time frame: During the surgery
Primary, assisted primary and secondary permeability of our accesses
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 34942337Hostalrich A, Boisroux T, Segal J, Lebas B, Ricco JB, Chaufour X. Assessment of Duplex Ultrasound Carried Out by the Vascular Surgeon After Locoregional Anesthesia for Preferred Arteriovenous Fistula Access. Ann Vasc Surg. 2022 Jul;83:117-123. doi: 10.1016/j.avsg.2021.11.014. Epub 2021 Dec 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arterio-venous Fistula, run by University Paul Sabatier of Toulouse at 1 site in France.
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 4 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 27 Jul 2021. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functionality of the AVF at the time of the postoperative (time frame: 6 weeks). 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 NCT04978155, which also lists 1 linked publication.
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 27 Jul 2021.