Vascular Access ComplicationCompOneNCT05156008
Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula
A study testing Ultrasound-guided vascular access in people with Vascular Access Complication and Vascular Access Site Bruising, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica.
Trial summary
Every patient need venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Vascular Access Site Bruising
- What is being tested?
- Ultrasound-guided vascular access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 15 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hip or knee arthroplasty
- BMI over 25
Who cannot join
- reoperation of endoprosthesis
- mental disorder
- age under 18
- sepsis
- protocol non-compliance
- gravidity
- patient refusal or no informed consent or both
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial
Every patient need venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Prospective randomized 2-arm study which is comparing success rate of ultrasound guided a palpation inserted cannulas in patients undergoing primary hip or knee arthroplasty.
The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.
Read the detailed description
More than 2 billion peripheral vascular cannulas (PVCs) are introduced globally each year. Each patient needs venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. Nevertheless, investigators still do not know how to fix them adequately, to work reliably for at least 72 hours.
Then there is a group of patients with difficult intravenous access (DIVA). These patients often have to undergo repeated painful punctures through the skin when introducing PVC. Many times well trained healthcare worker in the ultrasound-guided vascular access is needed to introduce PVC in DIVA patients. Up to one third of adult patients are DIVA. In overweight orthopedic patients, this subpopulation can reach up to 50% . Up to 64% PVC fails within 72 hours.
Several studies have shown that PVC introduced at the site of limb flexion (elbow, wrist), repeated punctures increase the risk of thrombosis, infection and phlebitis. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Investigators hypothesise that UGVA is superior in many parameters. The aim of our study is to compare two types of cannula insertion methods and their benefits and risks for patients. Ultrasound guided insertion and palpation guided insertion. To have evidence robust enough and after statistical analysis investigators decided for sample of 500 patients.
Investigators will evaluate data after 100, 250 and 500 patients. After statistical analysis will be calculate benefit/risk ratio for patients and take steps towards patient safety and satisfaction.
The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.
Patients are divided in two groups. Group A (insertion by palpation of vein): standard cannula (name brand "vasofix" BBraun) insertion through vein palpation and insertion in block room.
- prior insertion medical staff will fill in study protocol form A
Group B (UGVA): DIVA score calculation, Ultrasound-guided (name brand "deep access introcan" BBraun) cannula insertion
- prior insertion medical staff will fill in study protocol form B
In primary outcome investigators hypothesised that UGVA need less attempts to successful cannulation in comparison with vein cannulation by palpation. Investigators also think that deep vein cannula secured by UGVA will have lower failure rates by any means. In general there are several benefits in UGVA. On the other hand all above is applicable only in hands of well trained medical staff.
- Being tested
- Ultrasound-guided vascular access
- Keywords
- Ultrasound-guided vascular access, Randomized trial, Vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided vascular accessOther
Patients in this arm will have peripheral venous cannula inserted under realtime ultrasound guidance. Out of plane technique (in plane technique if too deep when tip of the needle is on vessel wall) used by experienced physicians in UGVA. Out of plane technique strictly used in step by step manner. That means moving probe with the tip of the needle to always locate its exact position, all the way into the vein. All performed insertions are carried out by skilled operators in UGVA with out of plane technique. Just before surgery in block room.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by standard palpation of vein under strict aseptic measures. Application of tourniquet on upper arm, palpation of vein, disinfection of skin and insertion of cannula. After two unsuccessful punctures, UGVA operator will step in and perform insertion of cannula with ultrasound. Medical staff will note: * number of attempts * time to obtain vascular access * type of cannula * DIVA score |
| Group B | Other | Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by ultrasound guided vascular access under strict aseptic measures. With or without tourniquet applied on upper arm operator will prescan vasculature of arm to choose applicable vein. After disinfection of skin optimal vein is on plain part of arm and cannula must not end in flection (elbow, wrist) of arm.
Medical staff will note:
* number of attempts, if 2 attempts fail, another operator will perform insertion
* time to obtain vascular access
* diameter of vein
* type of cannula
* DIVA score Receives: Other: Ultrasound-guided vascular access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound guided venous access need less attempts to successful cannulation
Number of punctures through skin defines number of attempts. Every puncture of skin with cannula is considered as attempt. Number of attempts are recorded in protocol as whole number. Does not matter with technique is used.
Measured: up to 24 hours
Secondary outcomes (7)
Ultrasound guided venous access time to successful cannulation
Time measurement starts when operator puts probe on patient and starts prescan of veins. Time measurement stops when cannula is successfully inserted confirmed by blood return after removal of internal metal piece. Is measured in minutes and seconds.
Measured: up to 24 hours
Venous access by palpation time to successful cannulation
Time measurement starts when nurse or physician starts to assess veins. Tourniquet application, disinfection of skin, palpation and cannulation are considered as process of cannulation. Time measurement stops when cannula is successfully inserted confirmed by blood return after removal of internal metal piece. Is measured in minutes and seconds.
Measured: up to 24 hours
Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing
During UGVA measurement of vein diameter measurement is mandatory. If diameter of vein in millimeters is equal to higher to Fr of catheter/cannula it should allow to draw blood without need for repeated vein punctures for blood sampling. Cannula G22 need 2,7mm vein diameter, Cannula G20 need 3,3mm vein diameter. Cannula G18 need 3,9mm vein diameter. In protocol there is mark on every day that cannula allows blood drawing. Is marked as yes-no immediately after insertion, and than every day until removal of cannula.
Measured: up to 5 days
UGVA will reduce the costs associated with perioperative venous access
In protocol there is mark for every material associated with blood drawing, venous access. After 5 days there will be sum of cost of material used. Up to 5 days or patient discharge.
Measured: up to 5 days
Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward
Every need of blood draw is marked in protocol, time spend to draw blood is marked in protocol. Measured in minutes and seconds. There are to scenarios. Blood draw through cannula: Measurement starts the moment nurse applies flush of saline, after that nurse will draw blood according to protocol, time measurement stops when saline flush is administered after successful blood draw. If not successful then measurement continues through blood draw by venipuncture.
Scenario two: blood draw through venipuncture: time measurement starts when nurse starts to assess veins for venipuncture. Time measurement stops after successful blood draw and after venipuncture site covering with tampon and tape.
Measured: up to 5 days
Insertion site infection occurrence after cannula placement
In protocol there is mark using "madonn scale - peripheral cannulas site infection 0 - 4" for every day in cannula is in use
Measured: up to 5 days
Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy
Inability to administer intravenous therapy through cannula from any reason is considered as failure of cannula. Failure rate is calculated from ratio of cannulas that did not fail to cannulas that failed. Is marked in results as percentage (%) as whole number and two decimals.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Jul 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion15 Jan 2024 (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 Vascular Access ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two arms. One arm ultrasound guided vascular access (UGVA) and control group standard vein cannulation with palpation.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Hlasny, MD, EDRA, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Jakub Hlasny, MD, Principal investigator, physician of anesthesia and intensive care department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156008
- Sponsor's protocol ID
- 26/2021
- Acronym
- CompOne
- Status last verified
- Oct 2022
- First submitted
- 15 Sep 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Witting MD. IV access difficulty: incidence and delays in an urban emergency department. J Emerg Med. 2012 Apr;42(4):483-7. doi: 10.1016/j.jemermed.2011.07.030. Epub 2011 Dec 2.
PubMed 22137793Alexandrou E, Ray-Barruel G, Carr PJ, Frost S, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM. International prevalence of the use of peripheral intravenous catheters. J Hosp Med. 2015 Aug;10(8):530-3. doi: 10.1002/jhm.2389. Epub 2015 Jun 3.
PubMed 26041384Ahlqvist M, Berglund B, Nordstrom G, Klang B, Wiren M, Johansson E. A new reliable tool (PVC assess) for assessment of peripheral venous catheters. J Eval Clin Pract. 2010 Dec;16(6):1108-15. doi: 10.1111/j.1365-2753.2009.01278.x.
PubMed 19925593Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, Hopkins T. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. BMJ. 2008 Jul 8;337(7662):a339. doi: 10.1136/bmj.a339.
PubMed 18614482Hlasny J, Alberty R, Hlavac M, Grgac I, Grey MT, Venglarcik M. Comparison of ultrasound-guided and palpation-inserted peripheral venous cannula in -patients before primary hip or knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Jul 21;24(1):467. doi: 10.1186/s13063-023-07459-x.
PubMed 37480132
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided and Palpation-inserted Peripheral Venous Cannula in Patients Before Primary Hip or Knee Arthroplasty a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05156008
- Acronym / sponsor ID
- CompOne / 26/2021
- Keywords
- Ultrasound-guided vascular access, Randomized trial, Vascular access
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 14 Dec 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.
Every patient need venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Prospective randomized 2-arm study which is comparing success rate of ultrasound guided a palpation inserted cannulas in patients undergoing primary hip or knee arthroplasty.
The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.
Detailed description
More than 2 billion peripheral vascular cannulas (PVCs) are introduced globally each year. Each patient needs venous access for surgery under anesthesia. It is the most frequently performed invasive procedure in medicine in the whole world. Nevertheless, investigators still do not know how to fix them adequately, to work reliably for at least 72 hours.
Then there is a group of patients with difficult intravenous access (DIVA). These patients often have to undergo repeated painful punctures through the skin when introducing PVC. Many times well trained healthcare worker in the ultrasound-guided vascular access is needed to introduce PVC in DIVA patients. Up to one third of adult patients are DIVA. In overweight orthopedic patients, this subpopulation can reach up to 50% . Up to 64% PVC fails within 72 hours.
Several studies have shown that PVC introduced at the site of limb flexion (elbow, wrist), repeated punctures increase the risk of thrombosis, infection and phlebitis. In expert groups, ultrasonographically guided vascular access (UGVA) appears to be a significantly better method, but studies on larger groups of patients are lacking.
Investigators hypothesise that UGVA is superior in many parameters. The aim of our study is to compare two types of cannula insertion methods and their benefits and risks for patients. Ultrasound guided insertion and palpation guided insertion. To have evidence robust enough and after statistical analysis investigators decided for sample of 500 patients.
Investigators will evaluate data after 100, 250 and 500 patients. After statistical analysis will be calculate benefit/risk ratio for patients and take steps towards patient safety and satisfaction.
The project will be managed according to the protocol of principles of Good Clinical Practice and valid regulations.
Patients are divided in two groups. Group A (insertion by palpation of vein): standard cannula (name brand "vasofix" BBraun) insertion through vein palpation and insertion in block room.
- prior insertion medical staff will fill in study protocol form A
Group B (UGVA): DIVA score calculation, Ultrasound-guided (name brand "deep access introcan" BBraun) cannula insertion
- prior insertion medical staff will fill in study protocol form B
In primary outcome investigators hypothesised that UGVA need less attempts to successful cannulation in comparison with vein cannulation by palpation. Investigators also think that deep vein cannula secured by UGVA will have lower failure rates by any means. In general there are several benefits in UGVA. On the other hand all above is applicable only in hands of well trained medical staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of two arms. One arm ultrasound guided vascular access (UGVA) and control group standard vein cannulation with palpation.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Patient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by standard palpation of vein under strict aseptic measures. Application of tourniquet on upper arm, palpation of vein, disinfection of skin and insertion of cannula. After two unsuccessful punctures, UGVA operator will step in and perform insertion of cannula with ultrasound. Medical staff will note: * number of attempts * time to obtain vascular access * type of cannula * DIVA score |
| Group B | Other | Other: Ultrasound-guided vascular accessPatient on the operating room, before primary hip or knee arthroplasty, will have his or her cannula inserted by ultrasound guided vascular access under strict aseptic measures. With or without tourniquet applied on upper arm operator will prescan vasculature of arm to choose applicable vein. After disinfection of skin optimal vein is on plain part of arm and cannula must not end in flection (elbow, wrist) of arm. Medical staff will note: * number of attempts, if 2 attempts fail, another operator will perform insertion * time to obtain vascular access * diameter of vein * type of cannula * DIVA score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary hip or knee arthroplasty
- BMI over 25
Key exclusion criteria (7 listed)
- reoperation of endoprosthesis
- mental disorder
- age under 18
- sepsis
- protocol non-compliance
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 |
|---|---|---|
| Ultrasound-guided vascular accessPatients in this arm will have peripheral venous cannula inserted under realtime ultrasound guidance. Out of plane technique (in plane technique if too deep when tip of the needle is on vessel wall) used by experienced physicians in UGVA. Out of plane technique strictly used in step by step manner. That means moving probe with the tip of the needle to always locate its exact position, all the way into the vein. All performed insertions are carried out by skilled operators in UGVA with out of plane technique. Just before surgery in block room. | Other | Group B |
Primary outcome
Ultrasound guided venous access need less attempts to successful cannulation
Time frame: up to 24 hours
Number of punctures through skin defines number of attempts. Every puncture of skin with cannula is considered as attempt. Number of attempts are recorded in protocol as whole number. Does not matter with technique is used.
7 secondary outcomes
Ultrasound guided venous access time to successful cannulation
Time frame: up to 24 hours
Venous access by palpation time to successful cannulation
Time frame: up to 24 hours
Ultrasound guided venous access allows insertion of cannulas suitable for blood drawing
Time frame: up to 5 days
UGVA will reduce the costs associated with perioperative venous access
Time frame: up to 5 days
Cannulas suitable for blood drawing, shortens the time a nurse spends drawing blood in the postoperative period at the ward
Time frame: up to 5 days
Insertion site infection occurrence after cannula placement
Time frame: up to 5 days
Long peripheral venous cannulas inserted under ultrasound guidance have low failure rate for intravenous therapy
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Results publication: PubMed 22137793Witting MD. IV access difficulty: incidence and delays in an urban emergency department. J Emerg Med. 2012 Apr;42(4):483-7. doi: 10.1016/j.jemermed.2011.07.030. Epub 2011 Dec 2.
- Results publication: PubMed 26041384Alexandrou E, Ray-Barruel G, Carr PJ, Frost S, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM. International prevalence of the use of peripheral intravenous catheters. J Hosp Med. 2015 Aug;10(8):530-3. doi: 10.1002/jhm.2389. Epub 2015 Jun 3.
- Results publication: PubMed 19925593Ahlqvist M, Berglund B, Nordstrom G, Klang B, Wiren M, Johansson E. A new reliable tool (PVC assess) for assessment of peripheral venous catheters. J Eval Clin Pract. 2010 Dec;16(6):1108-15. doi: 10.1111/j.1365-2753.2009.01278.x.
- Results publication: PubMed 18614482Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, Hopkins T. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. BMJ. 2008 Jul 8;337(7662):a339. doi: 10.1136/bmj.a339.
- Derived from this study: PubMed 37480132Hlasny J, Alberty R, Hlavac M, Grgac I, Grey MT, Venglarcik M. Comparison of ultrasound-guided and palpation-inserted peripheral venous cannula in -patients before primary hip or knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2023 Jul 21;24(1):467. doi: 10.1186/s13063-023-07459-x.
- Individual participant dataSharing planned: No
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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.
Jakub Hlasny, MD principal investigator
physician of anesthesia and intensive care department
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided vascular access in people with Vascular Access Complication and Vascular Access Site Bruising, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica.
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 7 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Viktoria Durajova, Master, PhD (+421907312462, vdurajova@nspbb.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound guided venous access need less attempts to successful cannulation (time frame: up to 24 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 NCT05156008, 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 12 Oct 2022.