AnesthesiaUSGPIVNCT03841864
Ultrasound Guided Peripheral IV Insertion
A study testing IV placement using ultrasound guidance vs traditional method in people with Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- IV placement using ultrasound guidance vs traditional method
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 13 May 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
- All patients requiring pre-operative IV
Who cannot join
- Emergency Surgery, patient refusal, non-english speaking (USGPIV modality available to them but time restrictive to consent for study), pediatrics
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Comparison of Traditional Technique Peripheral Intravenous [PIV] Catheter Insertion to the Utilization of Ultrasound Guidance for the Development of a Vein Classification System and Difficult IV Insertion Algorithm. A Prospective Observational Study
Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.
Read the detailed description
Study objective The purpose of this research study is to compare 2 established peripheral IV insertion techniques (traditional vs ultrasound guided) in order to develop an algorithmic approach to peripheral IV insertion. Patient characteristics, medical history and co-morbidities, in addition to a pre-insertion physical exam vein assessment, will allow for the introduction of a vein classification system and a difficult IV insertion algorithm. Selecting the optimal modality for initial IV insertion will decrease the total number of attempts, facilitate appropriate gauge and location of IV insertion, avoid central line placement, decrease IV insertion pain scores and improve patient satisfaction. Currently, ultrasound guided peripheral IV insertion is performed by the IV team at Cedars-Sinai Medical Center or a trained anesthesia provider as a rescue technique after multiple failed attempts by traditional technique. Secondary to the constraints of both trained providers and equipment resources, the cohort of difficult IV insertion patients are subjected to multiple traditional IV insertion attempts prior to escalation to ultrasound guidance and occasionally, unnecessary central line placements indicated by only poor intravenous access.
Primary end point: Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores, Patient satisfaction Secondary end points: Grade 2B and grade 3 vein classification ultrasound guided IV insertion success rate. Grade 1 and 2a vein classification 1st attempt IV insertion success rate. Grade 1 visualization 2nd attempt IV insertion success rate comparison of traditional vs ultrasound guided technique. Difficult IV insertion risk factors and associations, IV gauge and location, central line placement because of inadequate peripheral IV access
- Conditions
- Anesthesia
- Being tested
- IV placement using ultrasound guidance vs traditional method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV placement using ultrasound guidance vs traditional methodOther
Ultrasound guided IV placement
| Study group | Role | What they receive |
|---|---|---|
| Grade 1 Vein Visualization | Other | Visual vein classification grade described as excellent Visualization. Objective vein criteria to be included in this group are vein raised above skin and wider than 1mm. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement Receives: Other: IV placement using ultrasound guidance vs traditional method |
| Grade 2A Vein Visualization | Other | Veins that don't fit grade 1 or 2b classification (see respective group descriptions). This groups visual vein classification is described as fair visualization. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement Receives: Other: IV placement using ultrasound guidance vs traditional method |
| Grade 2b Vein Visualization | Other | Only faint vein shadow appearance described as poor visualization. Initial IV placement attempt will be ultrasound guided Receives: Other: IV placement using ultrasound guidance vs traditional method |
| Grade 3 Vein Visualization | Other | No vein visualization. Initial IV placement attempt will be ultrasound guided Receives: Other: IV placement using ultrasound guidance vs traditional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique
IV insertion success rate comparison on the second IV insertion attempt (after after 1x unsuccessful IV insertion using traditional technique) between traditional technique versus ultrasound guidance for grade 1 and 2a visual vein classification grades. For an 80% powered study to detect a 30% difference in success rate, an N of 50 is required in each group. Outcome will be successful vs unsuccessful IV insertion
Measured: 9 months after patient recruitment begins
Secondary outcomes (1)
Grade 2B and Grade 3 vein classification IV placement success rate
Ultrasound IV insertion success rate for grade 2B and grade 3 using ultrasound
Measured: 9 months after patient recruitment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start21 Jan 2019
- Primary completion30 Jun 2019
- Study completion13 May 2022
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 AnesthesiaStudies 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
- This study will partition all CSMC elective pre-operative patients into grade 1, 2a, 2b and 3 classifications to better assess the patient population distribution. Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores and patient satisfaction, will be compared amongst the 2 different modalities for peripheral IV insertion.
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, M.D., PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841864
- Sponsor's protocol ID
- Pro00054941
- Acronym
- USGPIV
- Status last verified
- May 2022
- First submitted
- 8 Feb 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final vein classification system and difficult IV algorithm. We will publish success rates of different modalities on different vein grades
Publications
Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
PubMed 36507736
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Traditional Technique Peripheral Intravenous [PIV] Catheter Insertion to the Utilization of Ultrasound Guidance for the Development of a Vein Classification System and Difficult IV Insertion Algorithm. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03841864
- Acronym / sponsor ID
- USGPIV / Pro00054941
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 15 Feb 2019 (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.
Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.
Detailed description
Study objective The purpose of this research study is to compare 2 established peripheral IV insertion techniques (traditional vs ultrasound guided) in order to develop an algorithmic approach to peripheral IV insertion. Patient characteristics, medical history and co-morbidities, in addition to a pre-insertion physical exam vein assessment, will allow for the introduction of a vein classification system and a difficult IV insertion algorithm. Selecting the optimal modality for initial IV insertion will decrease the total number of attempts, facilitate appropriate gauge and location of IV insertion, avoid central line placement, decrease IV insertion pain scores and improve patient satisfaction. Currently, ultrasound guided peripheral IV insertion is performed by the IV team at Cedars-Sinai Medical Center or a trained anesthesia provider as a rescue technique after multiple failed attempts by traditional technique. Secondary to the constraints of both trained providers and equipment resources, the cohort of difficult IV insertion patients are subjected to multiple traditional IV insertion attempts prior to escalation to ultrasound guidance and occasionally, unnecessary central line placements indicated by only poor intravenous access.
Primary end point: Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores, Patient satisfaction Secondary end points: Grade 2B and grade 3 vein classification ultrasound guided IV insertion success rate. Grade 1 and 2a vein classification 1st attempt IV insertion success rate. Grade 1 visualization 2nd attempt IV insertion success rate comparison of traditional vs ultrasound guided technique. Difficult IV insertion risk factors and associations, IV gauge and location, central line placement because of inadequate peripheral IV access
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study will partition all CSMC elective pre-operative patients into grade 1, 2a, 2b and 3 classifications to better assess the patient population distribution. Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores and patient satisfaction, will be compared amongst the 2 different modalities for peripheral IV insertion.
| Arm | Type | Receives |
|---|---|---|
| Grade 1 Vein Visualization | Other | Other: IV placement using ultrasound guidance vs traditional methodVisual vein classification grade described as excellent Visualization. Objective vein criteria to be included in this group are vein raised above skin and wider than 1mm. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement |
| Grade 2A Vein Visualization | Other | Other: IV placement using ultrasound guidance vs traditional methodVeins that don't fit grade 1 or 2b classification (see respective group descriptions). This groups visual vein classification is described as fair visualization. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement |
| Grade 2b Vein Visualization | Other | Other: IV placement using ultrasound guidance vs traditional methodOnly faint vein shadow appearance described as poor visualization. Initial IV placement attempt will be ultrasound guided |
| Grade 3 Vein Visualization | Other | Other: IV placement using ultrasound guidance vs traditional methodNo vein visualization. Initial IV placement attempt will be ultrasound guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients requiring pre-operative IV
Key exclusion criteria (1 listed)
- Emergency Surgery, patient refusal, non-english speaking (USGPIV modality available to them but time restrictive to consent for study), pediatrics
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 |
|---|---|---|
| IV placement using ultrasound guidance vs traditional methodUltrasound guided IV placement | Other | Grade 1 Vein Visualization, Grade 2A Vein Visualization, Grade 2b Vein Visualization, Grade 3 Vein Visualization |
Primary outcome
Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique
Time frame: 9 months after patient recruitment begins
IV insertion success rate comparison on the second IV insertion attempt (after after 1x unsuccessful IV insertion using traditional technique) between traditional technique versus ultrasound guidance for grade 1 and 2a visual vein classification grades. For an 80% powered study to detect a 30% difference in success rate, an N of 50 is required in each group. Outcome will be successful vs unsuccessful IV insertion
1 secondary outcome
Grade 2B and Grade 3 vein classification IV placement success rate
Time frame: 9 months after patient recruitment begins
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 17 May 2022.
- Derived from this study: PubMed 36507736Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.
- Individual participant dataSharing planned: No. Final vein classification system and difficult IV algorithm. We will publish success rates of different modalities on different vein grades
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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.
Roya Yumul, M.D., PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV placement using ultrasound guidance vs traditional method in people with Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
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: finished, as of the sponsor's last update on 17 May 2022. 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 United States. 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?
Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique (time frame: 9 months after patient recruitment begins). 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 NCT03841864, 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 17 May 2022.