CatheterizationPhase 4NCT01020461
Evaluation of Accuvein in Adult Patients
A Phase 4 study testing Accuvein in people with Catheterization, run by Hopital Foch at 1 site in France.
Trial summary
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization
- What is being tested?
- Accuvein
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Apr 2013
- Phase
- Phase 4
- 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
- adults requiring a venous blood sampling or the placement of a venous peripheral catheter
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.
- Conditions
- Catheterization
- Being tested
- Accuvein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuveinDevice
Accuvein will be used to facilitate venous blood sampling
AccuveinDevice
Accuvein will be used to facilitate peripheral IV catheter placement
| Study group | Role | What they receive |
|---|---|---|
| Venous blood sampling | Experimental | To use Accuvein to improve the effectiveness of venous blood sampling Receives: Device: Accuvein |
| Peripheral IV catheter placement | Experimental | To use Accuvein to improve the effectiveness of placing peripheral IV catheter Receives: Device: Accuvein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful blood sampling or to successful placement of IV catheter
Measured: one hour
Secondary outcomes (3)
Number of attempts required
Measured: Immediately after attempts
Pain
Measured: Immediately after attempts
Increases in the ease and efficiency of venous cannulation perceived by the operator)
Measured: Immediately after attempts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath"
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 CatheterizationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020461
- Sponsor's protocol ID
- 2009/43
- Status last verified
- Sep 2016
- First submitted
- 22 Nov 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.
PubMed 25176152
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients
- ClinicalTrials.gov ID
- NCT01020461
- Acronym / sponsor ID
- 2009/43
- Conditions
- Catheterization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath"
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Nov 2009 (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.
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous blood sampling | Experimental | Device: AccuveinTo use Accuvein to improve the effectiveness of venous blood sampling |
| Peripheral IV catheter placement | Experimental | Device: AccuveinTo use Accuvein to improve the effectiveness of placing peripheral IV catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults requiring a venous blood sampling or the placement of a venous peripheral catheter
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| AccuveinAccuvein will be used to facilitate venous blood sampling | Device | Venous blood sampling |
| AccuveinAccuvein will be used to facilitate peripheral IV catheter placement | Device | Peripheral IV catheter placement |
Primary outcome
Time to successful blood sampling or to successful placement of IV catheter
Time frame: one hour
3 secondary outcomes
Number of attempts required
Time frame: Immediately after attempts
Pain
Time frame: Immediately after attempts
Increases in the ease and efficiency of venous cannulation perceived by the operator)
Time frame: Immediately after attempts
Results and safety
The study was stopped early (reason given: Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath"). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Derived from this study: PubMed 25176152Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.
Related trials for Catheterization
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
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.
Marc Fischler, MD study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Accuvein in people with Catheterization, run by Hopital Foch 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 1 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: stopped early, as of the sponsor's last update on 23 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Arm "placement periph iv cath" COMPLETED - Arm "blood sampling" : study will not be performed because of the results of the arm "placement periph. iv cath"). 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?
Time to successful blood sampling or to successful placement of IV catheter (time frame: one hour). 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 NCT01020461, 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 23 Sep 2016.