Need for IV AccessNCT01870661
Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement
A study testing Long axis IV placement with ultrasound and Short axis IV placement with ultrasound in people with Need for IV Access, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Need for IV Access
- What is being tested?
- Long axis IV placement with ultrasound and Short axis IV placement with ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- 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
- A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU
- After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available
Who cannot join
- Need for vasopressors
- Need for TPN
- Need for hemodynamic monitoring
- Non English speaking patient
- Patients who are unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Isreal Medical Center
New York, New York, 10003
About this study
Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.
- Conditions
- Need for IV Access
- Being tested
- Long axis IV placement with ultrasound, Short axis IV placement with ultrasound
- Keywords
- Intravenous placement, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long axis IV placement with ultrasoundDevice
Peripheral IV placement with the ultrasound probe viewing the vessel in the long axis.
Short axis IV placement with ultrasoundDevice
Peripheral IV placement with the ultrasound probe viewing the vessel in the short axis.
| Study group | Role | What they receive |
|---|---|---|
| Long axis ultrasound placement of IV | Experimental | Long axis ultrasound placement of IV catheter Receives: Device: Long axis IV placement with ultrasound |
| Short axis ultrasound placement of IV | Active comparator | Long axis ultrasound placement of IV catheter Receives: Device: Short axis IV placement with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter survival
How many catheters survived for 3 days or as long as they are needed.
Measured: 3 days
Secondary outcomes (3)
Need for central venous access
Measured: for 3 days
success rate of peripheral IV using ultrasound assistance
Measured: 30 minutes
Complication rate
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Need for IV AccessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Silverberg, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870661
- Sponsor's protocol ID
- 035-13
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2013
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement
- ClinicalTrials.gov ID
- NCT01870661
- Acronym / sponsor ID
- 035-13
- Conditions
- Need for IV Access
- Keywords
- Intravenous placement, Ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jun 2013 (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.
Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long axis ultrasound placement of IV | Experimental | Device: Long axis IV placement with ultrasoundLong axis ultrasound placement of IV catheter |
| Short axis ultrasound placement of IV | Active comparator | Device: Short axis IV placement with ultrasoundLong axis ultrasound placement of IV catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU
- After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available
Key exclusion criteria (5 listed)
- Need for vasopressors
- Need for TPN
- Need for hemodynamic monitoring
- Non English speaking patient
- Patients who are unable to consent
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 |
|---|---|---|
| Long axis IV placement with ultrasoundPeripheral IV placement with the ultrasound probe viewing the vessel in the long axis. | Device | Long axis ultrasound placement of IV |
| Short axis IV placement with ultrasoundPeripheral IV placement with the ultrasound probe viewing the vessel in the short axis. | Device | Short axis ultrasound placement of IV |
Primary outcome
catheter survival
Time frame: 3 days
How many catheters survived for 3 days or as long as they are needed.
3 secondary outcomes
Need for central venous access
Time frame: for 3 days
success rate of peripheral IV using ultrasound assistance
Time frame: 30 minutes
Complication rate
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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.
Michael Silverberg, MD principal investigator
Beth Israel 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 Long axis IV placement with ultrasound and Short axis IV placement with ultrasound in people with Need for IV Access, run by Beth Israel 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Jun 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
catheter survival (time frame: 3 days). 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 25 Jun 2014.