AnesthesiaNCT05045352
Echogenic Versus Non-echogenic Needles for Venous Access
A study testing echogenic needles for intravenous access in people with Anesthesia and Vascular Access Complication, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Vascular Access Complication
- What is being tested?
- echogenic needles for intravenous access
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 12 Jan 2022to 30 Aug 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent.
- -
Who cannot join
- Patients that do not speak or understand Norwegian language.
- Skin disease or infection affecting the whole-body surface or within the area of examination.
- Patients with untreated coagulopathy
- Known vascular abnormality
- Any reason why, in the opinion of the investigators, the patient should not participate.
- Subject participates in a potentially confounding drug or device trial during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles
Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.
Read the detailed description
Patients undergoing certain surgical procedures and patients in intensive care unit require a central venous catheter (CVC) for infusion of medicaments and for monitoring. Central venous access (CVA) can be performed both with a blind technique or an ultrasound guided technique. A common place for CVA is the subclavian vein.
While many guidelines recommend the use of ultrasound for jugular access, there are no explicit recommendations for subclavian CVA For ultrasound guided CVA procedures good needle visualization is important to successfully place the needle and catheter in the correct position.
Echogenic needles can give better needle visualization when performing ultrasound guided CVA procedures. Theoretically, the use of echogenic needles should improve performance time and success rates, and reduce complication rates due to a better needling control.
The investigators will investigate the use of echogenic needles for vascular access.
A prospective randomized controlled trial design will be used. Echogenic needles will be compared with non-echogenic (standard) needles. The main null hypothesis states that there is no difference in access time between the needles.
- Conditions
- Anesthesia, Vascular Access Complication
- Being tested
- echogenic needles for intravenous access
- Keywords
- vascular access,, ultrasound guided, echogenic needles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echogenic needles for intravenous accessDevice
echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure
| Study group | Role | What they receive |
|---|---|---|
| Echogenic needle | Active comparator | venous access performed under ultrasound guidance with echogenic needles Receives: Device: echogenic needles for intravenous access |
| Non-Echogenic needles | No intervention | venous access performed under ultrasound guidance with non-echogenic needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from skin puncture of the needle until aspiration of venous blood.
Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access
Measured: 10 sec - 240 sec
Secondary outcomes (10)
Time from skin puncture until catheter in place
Time from skin puncture until the catheter in place in the subclavian vein.
Measured: 60 sec - 600 sec
Success with venous access in first needling attempt
Success in first attempt is defined as one skin puncture and directly into the subclavian vein
Measured: 60 sec - 600 sec
Number of needling attempts before venous access
Number of attempts is defined as the counted number of needle attempts intermitted by a needle withdrawal of at least 0.5 cm until aspiration of venous blood.
Measured: 60 sec - 600 sec
Number of skin punctures
Number of skin punctures is defined as the counted number of skin punctures until aspiration of venous blood.
Measured: 60 sec - 600 sec
The procedure was aborted
Discontinuation of the procedure or change of site for vascular access
Measured: 2 minutes - 20 minutes
Localization of catheter tip in x-ray
Catheter misplacement judged by x-ray. X-ray will be performed after the surgery and a blinded observer will describe the localization of the catheter.
Measured: 1 day- 7 days
The anaesthetists subjective experience with needle visualization
After performing the vascular access the anaesthetists are asked about how they found the visualization of the needle using a Numeric Rating Scale
Measured: 3 min- 20 min
The anaesthetists subjective experience with the needle placement
After performing the vascular access the anaesthetist is asked how the needle placement was using a Numeric Rating Scale
Measured: 3 minutes - 20 minutes
Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax
Adverse events, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized for safety information
Measured: 1 minutes- 1 day
Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax
Adverse device effects, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized
Measured: 5 minutes - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start12 Jan 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms Venous access either with echogenic needles or with non-echogenic needles
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trine Kåsine, Oslo University Hospital
- Investigators
- Trine Kåsine, MD, Principal investigator, Department of Anaesthesiology Oslo University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045352
- Sponsor's protocol ID
- REK 85090
- Status last verified
- Feb 2024
- First submitted
- 3 Sep 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles
- ClinicalTrials.gov ID
- NCT05045352
- Acronym / sponsor ID
- REK 85090
- Conditions
- Anesthesia, Vascular Access Complication
- Keywords
- vascular access,, ultrasound guided, echogenic needles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 16 Sep 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.
Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.
Detailed description
Patients undergoing certain surgical procedures and patients in intensive care unit require a central venous catheter (CVC) for infusion of medicaments and for monitoring. Central venous access (CVA) can be performed both with a blind technique or an ultrasound guided technique. A common place for CVA is the subclavian vein.
While many guidelines recommend the use of ultrasound for jugular access, there are no explicit recommendations for subclavian CVA For ultrasound guided CVA procedures good needle visualization is important to successfully place the needle and catheter in the correct position.
Echogenic needles can give better needle visualization when performing ultrasound guided CVA procedures. Theoretically, the use of echogenic needles should improve performance time and success rates, and reduce complication rates due to a better needling control.
The investigators will investigate the use of echogenic needles for vascular access.
A prospective randomized controlled trial design will be used. Echogenic needles will be compared with non-echogenic (standard) needles. The main null hypothesis states that there is no difference in access time between the needles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms Venous access either with echogenic needles or with non-echogenic needles
| Arm | Type | Receives |
|---|---|---|
| Echogenic needle | Active comparator | Device: echogenic needles for intravenous accessvenous access performed under ultrasound guidance with echogenic needles |
| Non-Echogenic needles | No intervention | –venous access performed under ultrasound guidance with non-echogenic needles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent.
- -
Key exclusion criteria (6 listed)
- Patients that do not speak or understand Norwegian language.
- Skin disease or infection affecting the whole-body surface or within the area of examination.
- Patients with untreated coagulopathy
- Known vascular abnormality
- Any reason why, in the opinion of the investigators, the patient should not participate.
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 |
|---|---|---|
| echogenic needles for intravenous accessechogenic needles for intravenous access (subclavian vein) ultrasound guided procedure | Device | Echogenic needle |
Primary outcome
Time from skin puncture of the needle until aspiration of venous blood.
Time frame: 10 sec - 240 sec
Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access
10 secondary outcomes
Time from skin puncture until catheter in place
Time frame: 60 sec - 600 sec
Success with venous access in first needling attempt
Time frame: 60 sec - 600 sec
Number of needling attempts before venous access
Time frame: 60 sec - 600 sec
Number of skin punctures
Time frame: 60 sec - 600 sec
The procedure was aborted
Time frame: 2 minutes - 20 minutes
Localization of catheter tip in x-ray
Time frame: 1 day- 7 days
The anaesthetists subjective experience with needle visualization
Time frame: 3 min- 20 min
The anaesthetists subjective experience with the needle placement
Time frame: 3 minutes - 20 minutes
Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax
Time frame: 1 minutes- 1 day
Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax
Time frame: 5 minutes - 1 week
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 28 Feb 2024.
- 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.
Trine Kåsine, MD principal investigator
Department of Anaesthesiology Oslo University Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echogenic needles for intravenous access in people with Anesthesia and Vascular Access Complication, run by Oslo University Hospital at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Norway. 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?
Time from skin puncture of the needle until aspiration of venous blood. (time frame: 10 sec - 240 sec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.