UltrasoundNCT01785225
Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
A study testing A product type of the modified commercial drape Tegaderm (R) in people with Ultrasound and Sterile Puncture Area, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement or blood donation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound, Sterile Puncture Area, Blood Sampling
- What is being tested?
- A product type of the modified commercial drape Tegaderm (R)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Mar 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 70 years of age
- mentally competent
- of good health
Who cannot join
- age below 18 or above 70 years of age
- daily use of blood thinner medication
- suffering from a chronic illness that requires frequent blood withdrawals
- heart conditions or vascular diseases
- People known to experience vasovagal episodes when having blood samples taken
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Skejby
Aarhus, 8200
Sofie Thorn, Student, 0045 61711623, thorn@studmed.au.dk
Sofie Thorn, Student
About this study
Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement or blood donation. The predominantly used venous for blood withdraw are in the cubital region because in this area venous are most superficial placed and most often visible for the human eye. However, when using the usual blind landmark and palpation method in this region, it often proves exceedingly difficult or even impossible to obtain peripheral venous access on patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various studies have shown that the success rate for establishing a vascular access with ultrasound compared to blind landmark technique is higher in patients with difficult access. When ultrasound is used to establish intravascular access, the prerequisite sterile puncture area can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or blood. A strict sterile procedure is important to reduce complications related to infection.The traditional way of coping with this is by covering the transducer and the wire in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band around the transducer and pulled tightly around the transducer foot to prevent artefacts from appearing on the screen. This is an expensive and time consuming method, and it still leaves the problem with gel in the puncture area.
The investigators have developed a method by where all these problems are solved by using, a slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning technique
Read more
The investigators hypothesize that it is possible to perform ultrasound-guided venous puncture with a sterile and dry puncture area and that puncture can be performed proximal and distal to the traditional puncture side.
It is a procedure presenting study that serves to demonstrate the feasibility of the method in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.
- Conditions
- Ultrasound, Sterile Puncture Area, Blood Sampling
- Being tested
- A product type of the modified commercial drape Tegaderm (R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A product type of the modified commercial drape Tegaderm (R)Device
Also called Drape: Tegaderm(R) Film (3M, USA).
We test if a product type of the modified commercial drape Tegaderm(R) can bee used when taking blood samples under the guidance af ultrasound. The drape is used to keep the puncture area sterile and clean of ultrasound gel.
| Study group | Role | What they receive |
|---|---|---|
| modified commercial drape Tegaderm (R) | Experimental | Not described Receives: Device: A product type of the modified commercial drape Tegaderm (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful blood withdrawals
Measured: During blood sampling
Secondary outcomes (1)
Image quality with and without sterile cover
Measured: During blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Sofie Thorn, Aarhus University Hospital
- Investigators
- Erik Sloth, Professor, MD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785225
- Sponsor's protocol ID
- 1-10-72-589-12
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
- ClinicalTrials.gov ID
- NCT01785225
- Acronym / sponsor ID
- 1-10-72-589-12
- Conditions
- Ultrasound, Sterile Puncture Area, Blood Sampling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 Feb 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.
Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement or blood donation. The predominantly used venous for blood withdraw are in the cubital region because in this area venous are most superficial placed and most often visible for the human eye. However, when using the usual blind landmark and palpation method in this region, it often proves exceedingly difficult or even impossible to obtain peripheral venous access on patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various studies have shown that the success rate for establishing a vascular access with ultrasound compared to blind landmark technique is higher in patients with difficult access. When ultrasound is used to establish intravascular access, the prerequisite sterile puncture area can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or blood. A strict sterile procedure is important to reduce complications related to infection.The traditional way of coping with this is by covering the transducer and the wire in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band around the transducer and pulled tightly around the transducer foot to prevent artefacts from appearing on the screen. This is an expensive and time consuming method, and it still leaves the problem with gel in the puncture area.
The investigators have developed a method by where all these problems are solved by using, a slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning technique
The investigators hypothesize that it is possible to perform ultrasound-guided venous puncture with a sterile and dry puncture area and that puncture can be performed proximal and distal to the traditional puncture side.
It is a procedure presenting study that serves to demonstrate the feasibility of the method in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| modified commercial drape Tegaderm (R) | Experimental | Device: A product type of the modified commercial drape Tegaderm (R) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 70 years of age
- mentally competent
- of good health
Key exclusion criteria (5 listed)
- age below 18 or above 70 years of age
- daily use of blood thinner medication
- suffering from a chronic illness that requires frequent blood withdrawals
- heart conditions or vascular diseases
- People known to experience vasovagal episodes when having blood samples taken
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 |
|---|---|---|
| A product type of the modified commercial drape Tegaderm (R)Also: Drape: Tegaderm(R) Film (3M, USA).We test if a product type of the modified commercial drape Tegaderm(R) can bee used when taking blood samples under the guidance af ultrasound. The drape is used to keep the puncture area sterile and clean of ultrasound gel. | Device | modified commercial drape Tegaderm (R) |
Primary outcome
Number of successful blood withdrawals
Time frame: During blood sampling
1 secondary outcome
Image quality with and without sterile cover
Time frame: During blood sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Erik Sloth, Professor, MD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A product type of the modified commercial drape Tegaderm (R) in people with Ultrasound and Sterile Puncture Area, run by Aarhus University Hospital at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofie Thorn, student (0045 61711623, thorn@studmed.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful blood withdrawals (time frame: During blood sampling). 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 7 Feb 2013.