Surgeries Requiring Arterial LinesNCT01757314
Comparing Palpation Guided and Ultrasound Guided Arterial Line Placement
An observational study of Surgeries Requiring Arterial Lines, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
When surgery is performed under general anesthesia, a catheter is placed in a vein to administer drugs and saline. During major operations, an additional catheter is placed in an artery in order to measure the blood pressure closely and withdraw blood samples at frequent intervals for various laboratory tests. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Surgeries Requiring Arterial Lines
- What is being tested?
- ultrasound technique and palpation technique
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2015
- Phase
- Observational
- 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 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: CA 1 and CA 2 residents assigned to surgical patients who require arterial lines due to complex surgical procedures
Who may be able to join
- resident in training is agreeable to consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Comparing Palpation Guided and Ultrasound Guided Arterial Catheter Placement by Anesthesiology Residents in Training
When surgery is performed under general anesthesia, a catheter is placed in a vein to administer drugs and saline. During major operations, an additional catheter is placed in an artery in order to measure the blood pressure closely and withdraw blood samples at frequent intervals for various laboratory tests. This arterial catheter is usually placed by feeling the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This procedure, at times, leads to delays and failures due to an inability to feel the arterial pulsation well either due to the patients' anatomy or the anesthetic effect. This study will determine whether training Anesthesiology Residents in the use of ultrasound technology and its application in identifying an artery can prevent the problems associated with the conventional palpation technique. Our finding will lead to better and safer anesthetic management of patients presenting for a major surgical procedure. Furthermore, the finding will help us in introducing the education and training of ultrasound-guided arterial catheter placement in our Residency Program.
The investigators propose to follow anesthesia residents over a course of 3 years assessing their skill level for both palpation and ultrasound technique.
Read the detailed description
This is an updated study on a previous IRB-approved research (0120070296) which was terminated prior to conclusion as the principal investigator terminated his employment at the UNDNJ. An arterial catheter is routinely placed immediately following induction of anesthesia, in major operative procedures, in order to measure blood pressure continuously, perform frequent blood-gas analysis and withdraw blood for repeated laboratory testing. The arterial catheter is traditionally placed blindly by palpating the radial artery of the patient. This way of placing a radial artery catheter can encounter delay or failure due to conditions such as obesity, arteriosclerosis, arterial spasm and anesthesia-induced hypotension. Our study will compare the performance of Anesthesiology Residents in placing an arterial catheter by the traditional palpation-guided technique and by the ultrasound-guided technique after training in ultrasound usage. The comparison will utilize the following parameters:
- Time taken to successfully place a catheter
- Number of attempts needed to place a catheter
- Number of puncture site changes encountered
- Failure rate of the resident with each technique
- The need for replacement of the catheter during surgery The data collection will be done by an independent observer, who is not a member of the anesthesia care team or research team. The Residents performing the catheter placement will not be members of the research team and will not have access to the data. If the Resident fails to place the catheter, the attending anesthesiologist will rescue by placing the arterial catheter himself by a method of his choice. In the previous study, there was a trend toward a reduced failure rate and a decreased time for insertion with the ultrasound technique. In this study, the investigators will introduce the research to the first-year Residents and repeat the exercise during their second and third year of training in a longitudinal fashion to assess the progress during anesthesia training. The investigators plan to enroll eight residents from the first-year class. Each resident will perform eight arterial catheter placements with each technique. In addition, compared to the previous study, a more advanced ultrasound machine will be used which will provide better visualization of the radial artery.
- Conditions
- Surgeries Requiring Arterial Lines
- Being tested
- ultrasound technique, palpation technique
- Keywords
- arterial lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound techniqueBehavioural
instruction in the ultrasound technique
palpation techniqueOther
placement of a line via palpation technique
| Study group | Role | What they receive |
|---|---|---|
| CA 1 and 2 anethesia residents | palpation technique Receives: Other: palpation technique | |
| Ca1 and 2 residents | ultrasound guided technique Receives: Behavioral: ultrasound technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to successful placement of catheter
Measured: residents to be timed over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: already several publications in the literature
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgeries Requiring Arterial LinesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757314
- Sponsor's protocol ID
- 2012001193
- Status last verified
- Sep 2015
- First submitted
- 27 Sep 2012
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Palpation Guided and Ultrasound Guided Arterial Catheter Placement by Anesthesiology Residents in Training
- ClinicalTrials.gov ID
- NCT01757314
- Acronym / sponsor ID
- 2012001193
- Conditions
- Surgeries Requiring Arterial Lines
- Keywords
- arterial lines
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: already several publications in the literature
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Dec 2012 (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.
When surgery is performed under general anesthesia, a catheter is placed in a vein to administer drugs and saline. During major operations, an additional catheter is placed in an artery in order to measure the blood pressure closely and withdraw blood samples at frequent intervals for various laboratory tests. This arterial catheter is usually placed by feeling the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This procedure, at times, leads to delays and failures due to an inability to feel the arterial pulsation well either due to the patients' anatomy or the anesthetic effect. This study will determine whether training Anesthesiology Residents in the use of ultrasound technology and its application in identifying an artery can prevent the problems associated with the conventional palpation technique. Our finding will lead to better and safer anesthetic management of patients presenting for a major surgical procedure. Furthermore, the finding will help us in introducing the education and training of ultrasound-guided arterial catheter placement in our Residency Program.
The investigators propose to follow anesthesia residents over a course of 3 years assessing their skill level for both palpation and ultrasound technique.
Detailed description
This is an updated study on a previous IRB-approved research (0120070296) which was terminated prior to conclusion as the principal investigator terminated his employment at the UNDNJ. An arterial catheter is routinely placed immediately following induction of anesthesia, in major operative procedures, in order to measure blood pressure continuously, perform frequent blood-gas analysis and withdraw blood for repeated laboratory testing. The arterial catheter is traditionally placed blindly by palpating the radial artery of the patient. This way of placing a radial artery catheter can encounter delay or failure due to conditions such as obesity, arteriosclerosis, arterial spasm and anesthesia-induced hypotension. Our study will compare the performance of Anesthesiology Residents in placing an arterial catheter by the traditional palpation-guided technique and by the ultrasound-guided technique after training in ultrasound usage. The comparison will utilize the following parameters:
- Time taken to successfully place a catheter
- Number of attempts needed to place a catheter
- Number of puncture site changes encountered
- Failure rate of the resident with each technique
- The need for replacement of the catheter during surgery The data collection will be done by an independent observer, who is not a member of the anesthesia care team or research team. The Residents performing the catheter placement will not be members of the research team and will not have access to the data. If the Resident fails to place the catheter, the attending anesthesiologist will rescue by placing the arterial catheter himself by a method of his choice. In the previous study, there was a trend toward a reduced failure rate and a decreased time for insertion with the ultrasound technique. In this study, the investigators will introduce the research to the first-year Residents and repeat the exercise during their second and third year of training in a longitudinal fashion to assess the progress during anesthesia training. The investigators plan to enroll eight residents from the first-year class. Each resident will perform eight arterial catheter placements with each technique. In addition, compared to the previous study, a more advanced ultrasound machine will be used which will provide better visualization of the radial artery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA 1 and 2 anethesia residents | – | Other: palpation techniquepalpation technique |
| Ca1 and 2 residents | – | Behavioral: ultrasound techniqueultrasound guided technique |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- CA 1 and CA 2 residents assigned to surgical patients who require arterial lines due to complex surgical procedures
Key inclusion criteria (1 listed)
- resident in training is agreeable to consent
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 |
|---|---|---|
| ultrasound techniqueinstruction in the ultrasound technique | Behavioural | Ca1 and 2 residents |
| palpation techniqueplacement of a line via palpation technique | Other | CA 1 and 2 anethesia residents |
Primary outcome
time to successful placement of catheter
Time frame: residents to be timed over 2 years
Results and safety
The study was stopped early (reason given: already several publications in the literature). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgeries Requiring Arterial Lines, run by Rutgers, The State University of New Jersey 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: stopped early, as of the sponsor's last update on 28 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 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 stopped early (reason given: already several publications in the literature). 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 placement of catheter (time frame: residents to be timed over 2 years). 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 Sep 2016.