HypotensionWASHCANNCT03027323
Washington Study of AxoTrack-Guided Central Venous Cannulation
A study testing AxoTrack System in people with Hypotension, run by University of Washington at 1 site in United States.
Trial summary
Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to critical levels due to several possible reasons. The medical staff treating the patient will need to find out the reason for your drop in blood pressure as soon as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- AxoTrack System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2017to Dec 2020
- 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
- Confirmed systolic blood pressure < 90 mmHg in emergency department;
- Aged at least 18 years; and
- Need for CVC in emergency department.
Who cannot join
- Preexisting written do not attempt resuscitation order;
- Prisoners;
- Pregnant;
- ST-elevation on initial 12-lead electrocardiogram;
- Blunt or penetrating traumatic injury;
- Major burn;
Show all 11Show fewer
- Exsanguination;
- Obese (i.e. estimated body mass index > 30 kg/m2);
- Known coagulation disorders;
- Contraindication to CVC by subclavian route; or
- Patients in extremis for whom placement of the device would delay emergent care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to critical levels due to several possible reasons. The medical staff treating the patient will need to find out the reason for your drop in blood pressure as soon as possible. When treating low blood pressure, the medical staff typically performs a procedure called central venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under the collarbone) by inserting a needle into the vein. By doing this, the medical staff can measure the pressures in the patient's veins or give medicine to the patient while they are in the hospital.
The purpose of this study is to compare the time needed to complete CVC using the AxoTrack device to CVC guided by landmarks on a patient's body. The investigators expect that there will be a maximum of 30 patients enrolled in this study.
Read the detailed description
Central venous cannulation (CVC) is commonly performed to give volume resuscitation and parenteral medications to patients with time sensitive conditions such as severe traumatic injury or undifferentiated shock. CVC via the subclavian route is associated with more frequent technical complications but less frequent infection or thrombosis as compared with via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic ultrasound device is associated with a lower technical failure rate (overall and on first attempt), fewer punctures, faster access, and fewer mechanical complications as compared with guidance by anatomical landmarks when performed via the internal jugular vein. It remains unclear whether CVC guided by real-time ultrasound is associated with significantly lower failure and complication rates as compared with CVC guided by landmarks when performed via the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of complications, number of punctures, and the time between skin penetration and the aspiration of venous blood into the syringe as compared with guidance by landmarks. A limitation of guidance by a traditional diagnostic ultrasound device is it that it may require an assistant to perform, which may not be feasible when treating time sensitive conditions or in low resource settings. In addition, most traditional ultrasound probes are not designed to image the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance system recently cleared for human use by the United States Food and Drug Administration. It is intended to facilitate CVC by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein. It remains unclear whether CVC guided by AxoTrack reduces procedure times and complication rates when compared with CVC using landmark guidance in patients with undifferentiated hypotension.
- Conditions
- Hypotension
- Being tested
- AxoTrack System
- Keywords
- undifferentiated hypotension, central venous cannulation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxoTrack SystemDevice
The AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein.
| Study group | Role | What they receive |
|---|---|---|
| AxoTrack System guided CVC insertion | Other | AxoTrack System guided CVC Receives: Device: AxoTrack System |
| CVC insertion guided by landmark | No intervention | Anatomical landmarks to guide CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to insertion of CVC into a subclavian vein
The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein
Measured: 0-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start10 Feb 2017 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Study not funded; no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graham Nichol, University of Washington
- Investigators
- Graham Nichol, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027323
- Sponsor's protocol ID
- STUDY00000958
- Acronym
- WASHCAN
- Status last verified
- Oct 2022
- First submitted
- 19 Jan 2017
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washington Study of AxoTrack-Guided Central Venous Cannulation
- ClinicalTrials.gov ID
- NCT03027323
- Acronym / sponsor ID
- WASHCAN / STUDY00000958
- Conditions
- Hypotension
- Keywords
- undifferentiated hypotension, central venous cannulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded; no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 10 Feb 2017 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jan 2017 (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.
Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to critical levels due to several possible reasons. The medical staff treating the patient will need to find out the reason for your drop in blood pressure as soon as possible. When treating low blood pressure, the medical staff typically performs a procedure called central venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under the collarbone) by inserting a needle into the vein. By doing this, the medical staff can measure the pressures in the patient's veins or give medicine to the patient while they are in the hospital.
The purpose of this study is to compare the time needed to complete CVC using the AxoTrack device to CVC guided by landmarks on a patient's body. The investigators expect that there will be a maximum of 30 patients enrolled in this study.
Detailed description
Central venous cannulation (CVC) is commonly performed to give volume resuscitation and parenteral medications to patients with time sensitive conditions such as severe traumatic injury or undifferentiated shock. CVC via the subclavian route is associated with more frequent technical complications but less frequent infection or thrombosis as compared with via the internal jugular or femoral veins. Traditionally CVC via the subclavian vein is guided by anatomical landmarks. CVC guided by real-time use of traditional diagnostic ultrasound device is associated with a lower technical failure rate (overall and on first attempt), fewer punctures, faster access, and fewer mechanical complications as compared with guidance by anatomical landmarks when performed via the internal jugular vein. It remains unclear whether CVC guided by real-time ultrasound is associated with significantly lower failure and complication rates as compared with CVC guided by landmarks when performed via the subclavian vein. CVC guided by real-time ultrasound may reduce the incidence of complications, number of punctures, and the time between skin penetration and the aspiration of venous blood into the syringe as compared with guidance by landmarks. A limitation of guidance by a traditional diagnostic ultrasound device is it that it may require an assistant to perform, which may not be feasible when treating time sensitive conditions or in low resource settings. In addition, most traditional ultrasound probes are not designed to image the subclavian vein behind the clavicle. The AxoTrack system is a novel ultrasound guidance system recently cleared for human use by the United States Food and Drug Administration. It is intended to facilitate CVC by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein. It remains unclear whether CVC guided by AxoTrack reduces procedure times and complication rates when compared with CVC using landmark guidance in patients with undifferentiated hypotension.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AxoTrack System guided CVC insertion | Other | Device: AxoTrack SystemAxoTrack System guided CVC |
| CVC insertion guided by landmark | No intervention | –Anatomical landmarks to guide CVC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed systolic blood pressure < 90 mmHg in emergency department;
- Aged at least 18 years; and
- Need for CVC in emergency department.
Key exclusion criteria (11 listed)
- Preexisting written do not attempt resuscitation order;
- Prisoners;
- Pregnant;
- ST-elevation on initial 12-lead electrocardiogram;
- Blunt or penetrating traumatic injury;
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 |
|---|---|---|
| AxoTrack SystemThe AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein. | Device | AxoTrack System guided CVC insertion |
Primary outcome
Time to insertion of CVC into a subclavian vein
Time frame: 0-30 minutes
The time it takes for the care provider to insert the central venous cannulation device into the subclavian vein
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 28 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Graham Nichol, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AxoTrack System in people with Hypotension, run by University of Washington 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 3 inclusion and 11 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 28 Oct 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 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?
Time to insertion of CVC into a subclavian vein (time frame: 0-30 minutes). 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 Oct 2022.