ObesityNCT01975974
Technique for Successful Ultrasound-guided Peripheral Vascular Access
An observational study of Obesity and Vascular Diseases, run by University of Iowa at 1 site in United States.
Trial summary
Obtaining peripheral vascular access in medical patients is a necessary procedure for many healthcare providers. Peripheral vascular access is traditionally performed using palpation or visual inspection to identify appropriate points of entry in the vasculature after which a needle and catheter are threaded through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Vascular Diseases
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population will be surgical patients requiring peripheral intravenous access.
Who may be able to join
- morbid obese surgical patients requiring large bore IV.
- no visible intravenous access in upper arm
Who cannot join
- 1) No target vein by US screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hosptials and Clinics
Iowa City, Iowa, 52242
About this study
Obtaining peripheral vascular access in medical patients is a necessary procedure for many healthcare providers. Peripheral vascular access is traditionally performed using palpation or visual inspection to identify appropriate points of entry in the vasculature after which a needle and catheter are threaded through the skin and surround fascia into the vessel of interest. This procedure, one of the most common procedures in the medical field including both artery and vein access, is not 100% successfully attempted. Operator skill heavily influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient populations have difficult peripheral vessels to identify by palpation or visual inspection and past operators would be forced to perform the procedure blind based on anatomical landmarks. Recently, to aid vascular identification and increase cannulation success, a number of alternative techniques for peripheral vascular access have been described including ultrasound-guided.
Ultrasound-guided vascular access has been utilized in vascular access with improved success rate. However, even with ultrasound guidance the first attempt success rate of cannulation was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular access is most likely due to failure to advance the catheter into the vessel even the vessel was successfully punctured. The investigators propose a specific technique and the positive "Target Sign" as a means to obtain almost 100% successful peripheral vascular access.
The investigators plan to enroll 100 surgical patients in the above study and study procedures will not differ from what a patient in the operating room under the care of anesthesia faculty would receive. The above study is simply a way to identify the steps regarding a specific technique.
Read the detailed description
The subjects (patients) will be brought to the Main Operating Room after their time in the Day of Surgery Admissions (DOSA) at the discretion of the attending physicians and surgical team. The patients will not be required to do anything different from standard anesthesia and surgical practice at the hospital. Subjects will come to the operating room suite and the usual monitors (electrocardiogram, non-invasive blood pressure, and oxygen saturation) will be placed.
Prior to the routine induction of anesthesia, peripheral vascular access is usually obtained. In regards to the subject population, peripheral vascular access is predicted to be more difficult due to lack of visualization of the peripheral vessels. The skin will be prepped with chlorhexidine, draped, and all subsequent procedures will be performed in sterile fashion. The attending physician and/or resident will use the L25x Sonosite transducer with the Sonosite Edge® (Washington, US) to identify a peripheral vessel in the upper extremity for cannulation. After identification of the vessel, the operator will line the L25x Sonosite transducer to place the vessel horizontally midline on the Sonosite Edge® screen to give the most available viewing area. A BD Insyte® Autoguard® 16G shielded IV catheter (Becton Dickinson Infusion Therapy Systems Inc., Utah, US) will be advanced toward the vessel at an approximately 10˚ angle. Once the needle tip is identified on the Sonosite Edge® monitor in short axis view, the following steps will ensue:
- Advance the needle toward the vessel slowly, adjusting the ultrasound transducer position and angle to continue to keep the needle tip and vessel identified on the Sonosite Edge® monitor.
- Puncture the anterior wall of the vessel with the needle tip
- Confirm needle tip placement in vessel
- Advance the needle within the vessel 5mm under continuous visualization
- View and record confirmation of "Target Sign" on ultrasound monitor
- Positive Target Sign=needle tip is identified on ultrasound monitor within vessel and is able to move freely within the vessel, similar to a circle with a target in the middle which is able to move. This confirms the needle is unrestricted in the vessel.
- Negative Target Sign=needle is identified on ultrasound monitor within vessel, but is unable to move freely within the vessel without dragging the vessel wall with needle movement. This confirms the needle is transfixed on the posterior wall of the vessel
- Thread the catheter over the needle.
- At this point, the catheter could be advanced either with or without a guidewire at the operator's discretion Members of the research team will be available for verbal assistance throughout this procedure.
Number of attempts and time to successful vessel cannulation will be measured, starting from when either the operator's fingers or the ultrasound probe made contact with the patient's skin. Successful vessel cannulation will be defined as a flowing IV bag of saline after connection and confirmation of flow via fluid agitation in vessel identified via ultrasound.
This procedure will be incorporated in the subjects standard of care and will not extend the time of operation.
At this point, patient participation in the study will be over and surgical operation under the discretion of the surgical team. The video recording of the Target Sign will be saved and given to a member of the research team unknowing of the success of the cannulation. The member of the research team will decide, based on the ultrasound video recording of a positive or negative Target Sign, if the cannulation was successful or unsuccessful. The viewer will record his/her answers and compare with the actual result of the cannulation.
Analysis of unsuccessful and successful cannulations will be compared with a Positive or Negative Target Sign. No additional long-term followup will occur.
- Conditions
- Obesity, Vascular Diseases
- Being tested
- Ultrasound
- Keywords
- vascular, access, ultrasound
- Medical subject headings
- Obesity, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Using ultrasound as a guide for peripheral venous cannulation in obese patients
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Ultrasound guided peripheral vascular access Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful First Attempt Peripheral Venous Cannulation
we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Ueda, University of Iowa
- Investigators
- Kenichi Ueda, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975974
- Sponsor's protocol ID
- 201307701
- Status last verified
- Apr 2017
- First submitted
- 2 Aug 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: we are not planning on sharing the data
Publications
Ueda K, Hussey P. Dynamic Ultrasound-Guided Short-Axis Needle Tip Navigation Technique for Facilitating Cannulation of Peripheral Veins in Obese Patients. Anesth Analg. 2017 Mar;124(3):831-833. doi: 10.1213/ANE.0000000000001653.
PubMed 27984247
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technique for Successful Ultrasound-guided Peripheral Vascular Access
- ClinicalTrials.gov ID
- NCT01975974
- Acronym / sponsor ID
- 201307701
- Conditions
- Obesity, Vascular Diseases
- Keywords
- vascular, access, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Posted 20 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obtaining peripheral vascular access in medical patients is a necessary procedure for many healthcare providers. Peripheral vascular access is traditionally performed using palpation or visual inspection to identify appropriate points of entry in the vasculature after which a needle and catheter are threaded through the skin and surround fascia into the vessel of interest. This procedure, one of the most common procedures in the medical field including both artery and vein access, is not 100% successfully attempted. Operator skill heavily influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient populations have difficult peripheral vessels to identify by palpation or visual inspection and past operators would be forced to perform the procedure blind based on anatomical landmarks. Recently, to aid vascular identification and increase cannulation success, a number of alternative techniques for peripheral vascular access have been described including ultrasound-guided.
Ultrasound-guided vascular access has been utilized in vascular access with improved success rate. However, even with ultrasound guidance the first attempt success rate of cannulation was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular access is most likely due to failure to advance the catheter into the vessel even the vessel was successfully punctured. The investigators propose a specific technique and the positive "Target Sign" as a means to obtain almost 100% successful peripheral vascular access.
The investigators plan to enroll 100 surgical patients in the above study and study procedures will not differ from what a patient in the operating room under the care of anesthesia faculty would receive. The above study is simply a way to identify the steps regarding a specific technique.
Detailed description
The subjects (patients) will be brought to the Main Operating Room after their time in the Day of Surgery Admissions (DOSA) at the discretion of the attending physicians and surgical team. The patients will not be required to do anything different from standard anesthesia and surgical practice at the hospital. Subjects will come to the operating room suite and the usual monitors (electrocardiogram, non-invasive blood pressure, and oxygen saturation) will be placed.
Prior to the routine induction of anesthesia, peripheral vascular access is usually obtained. In regards to the subject population, peripheral vascular access is predicted to be more difficult due to lack of visualization of the peripheral vessels. The skin will be prepped with chlorhexidine, draped, and all subsequent procedures will be performed in sterile fashion. The attending physician and/or resident will use the L25x Sonosite transducer with the Sonosite Edge® (Washington, US) to identify a peripheral vessel in the upper extremity for cannulation. After identification of the vessel, the operator will line the L25x Sonosite transducer to place the vessel horizontally midline on the Sonosite Edge® screen to give the most available viewing area. A BD Insyte® Autoguard® 16G shielded IV catheter (Becton Dickinson Infusion Therapy Systems Inc., Utah, US) will be advanced toward the vessel at an approximately 10˚ angle. Once the needle tip is identified on the Sonosite Edge® monitor in short axis view, the following steps will ensue:
- Advance the needle toward the vessel slowly, adjusting the ultrasound transducer position and angle to continue to keep the needle tip and vessel identified on the Sonosite Edge® monitor.
- Puncture the anterior wall of the vessel with the needle tip
- Confirm needle tip placement in vessel
- Advance the needle within the vessel 5mm under continuous visualization
- View and record confirmation of "Target Sign" on ultrasound monitor
- Positive Target Sign=needle tip is identified on ultrasound monitor within vessel and is able to move freely within the vessel, similar to a circle with a target in the middle which is able to move. This confirms the needle is unrestricted in the vessel.
- Negative Target Sign=needle is identified on ultrasound monitor within vessel, but is unable to move freely within the vessel without dragging the vessel wall with needle movement. This confirms the needle is transfixed on the posterior wall of the vessel
- Thread the catheter over the needle.
- At this point, the catheter could be advanced either with or without a guidewire at the operator's discretion Members of the research team will be available for verbal assistance throughout this procedure.
Number of attempts and time to successful vessel cannulation will be measured, starting from when either the operator's fingers or the ultrasound probe made contact with the patient's skin. Successful vessel cannulation will be defined as a flowing IV bag of saline after connection and confirmation of flow via fluid agitation in vessel identified via ultrasound.
This procedure will be incorporated in the subjects standard of care and will not extend the time of operation.
At this point, patient participation in the study will be over and surgical operation under the discretion of the surgical team. The video recording of the Target Sign will be saved and given to a member of the research team unknowing of the success of the cannulation. The member of the research team will decide, based on the ultrasound video recording of a positive or negative Target Sign, if the cannulation was successful or unsuccessful. The viewer will record his/her answers and compare with the actual result of the cannulation.
Analysis of unsuccessful and successful cannulations will be compared with a Positive or Negative Target Sign. No additional long-term followup will occur.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | Device: UltrasoundUltrasound guided peripheral vascular access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be surgical patients requiring peripheral intravenous access.
Key inclusion criteria (2 listed)
- morbid obese surgical patients requiring large bore IV.
- no visible intravenous access in upper arm
Key exclusion criteria (1 listed)
- 1) No target vein by US screening
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 |
|---|---|---|
| UltrasoundUsing ultrasound as a guide for peripheral venous cannulation in obese patients | Device | Ultrasound |
Primary outcome
Successful First Attempt Peripheral Venous Cannulation
Time frame: one day
we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27984247Ueda K, Hussey P. Dynamic Ultrasound-Guided Short-Axis Needle Tip Navigation Technique for Facilitating Cannulation of Peripheral Veins in Obese Patients. Anesth Analg. 2017 Mar;124(3):831-833. doi: 10.1213/ANE.0000000000001653.
- Individual participant dataSharing planned: No. we are not planning on sharing the data
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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.
Kenichi Ueda, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Vascular Diseases, run by University of Iowa 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 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 30 May 2017. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful First Attempt Peripheral Venous Cannulation (time frame: one day). 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 NCT01975974, 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 30 May 2017.