Overweight and ObesityDUSTNCT04412967
Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
A study testing Dynamic ultrasound-guided short-axis needle tip navigation and Standard technique of placing a PVC in people with Overweight and Obesity and Emergencies, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Emergencies
- What is being tested?
- Dynamic ultrasound-guided short-axis needle tip navigation and Standard technique of placing a PVC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2017to 3 Jun 2018
- 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
- REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"
- 18 years old
- BMI ≥25 Kg/m2
- Need of PVC according to Emergency department guidelines
- Able to give written informed consent
Who cannot join
- Unable or unwilling to provide informed consent
- Life threatening patient status (REETS prioritization level of "Red")
- Immunosuppression
- Pregnant or lactating women
- Blood infections
- Puncture zone skin damaged (burns, eczema, infection)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital Linköping
Linköping, Östergötland County, 58185
About this study
Official title: A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.
This was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2.
Read more
Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).
DUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.
- Conditions
- Overweight and Obesity, Emergencies
- Being tested
- Dynamic ultrasound-guided short-axis needle tip navigation, Standard technique of placing a PVC
- Keywords
- Nurse led, Ultrasound, Emergency department, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic ultrasound-guided short-axis needle tip navigationDevice
placement of peripheral venous catheters using ultrasound guided technique
Standard technique of placing a PVCOther
Standard technique with palpation or Visual inspection of the pvc placement site
| Study group | Role | What they receive |
|---|---|---|
| Standard Technique PVC placement | Active comparator | Standard PVC placement technique Receives: Other: Standard technique of placing a PVC |
| DUST | Experimental | Dynamic ultrasound-guided short-axis needle tip navigation (DUST) Receives: Device: Dynamic ultrasound-guided short-axis needle tip navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to application
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
Measured: 1 hour
Number of cannulation attempts
The total number of cannulation attempts performed per patient
Measured: 1 hour
Secondary outcomes (2)
Patient satisfaction
The perceived satisfaction of the patient as indicated by Numeric Rating scale (NRS, 0 = not satisfied, 10 = maximum satisfaction)
Measured: 1 hour
Perceived Pain
The perceived pain of the patient as indicated by Numeric Rating scale (NRS, 0 = no pain, 10 = the worst pain possible)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 May 2017
- Primary completion16 May 2018
- Study completion3 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Wilhelms, University Hospital, Linkoeping
- Investigators
- Daniel Wilhelms, Phd, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412967
- Sponsor's protocol ID
- SE-2020 JG DUST
- Acronym
- DUST
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Comparison of Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique
- ClinicalTrials.gov ID
- NCT04412967
- Acronym / sponsor ID
- DUST / SE-2020 JG DUST
- Conditions
- Overweight and Obesity, Emergencies
- Keywords
- Nurse led, Ultrasound, Emergency department, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 3 Jun 2018 (actual)
- First posted
- 2 Jun 2020 (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.
Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.
This was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2.
Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).
DUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Technique PVC placement | Active comparator | Other: Standard technique of placing a PVCStandard PVC placement technique |
| DUST | Experimental | Device: Dynamic ultrasound-guided short-axis needle tip navigationDynamic ultrasound-guided short-axis needle tip navigation (DUST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"
- 18 years old
- BMI ≥25 Kg/m2
- Need of PVC according to Emergency department guidelines
- Able to give written informed consent
Key exclusion criteria (6 listed)
- Unable or unwilling to provide informed consent
- Life threatening patient status (REETS prioritization level of "Red")
- Immunosuppression
- Pregnant or lactating women
- Blood infections
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 |
|---|---|---|
| Dynamic ultrasound-guided short-axis needle tip navigationplacement of peripheral venous catheters using ultrasound guided technique | Device | DUST |
| Standard technique of placing a PVCStandard technique with palpation or Visual inspection of the pvc placement site | Other | Standard Technique PVC placement |
Primary outcome
Time to application
Time frame: 1 hour
Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.
Number of cannulation attempts
Time frame: 1 hour
The total number of cannulation attempts performed per patient
2 secondary outcomes
Patient satisfaction
Time frame: 1 hour
Perceived Pain
Time frame: 1 hour
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 30 Jun 2020.
- 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.
Daniel Wilhelms, Phd principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic ultrasound-guided short-axis needle tip navigation and Standard technique of placing a PVC in people with Overweight and Obesity and Emergencies, run by University Hospital, Linkoeping at 1 site in Sweden.
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 5 inclusion and 6 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 Jun 2020. 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 Sweden. 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?
Time to application (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 30 Jun 2020.