ExtravasationNCT03889678
Color Doppler and Peripheral Venous Catheters
An observational study of Extravasation and Vein Injury, run by Augusta University at 1 site in United States.
Trial summary
Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients. Methods: A prospective study is conducted in adult (>18 years old) patients scheduled to undergo elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extravasation, Vein Injury
- What is being tested?
- Color flow doppler
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2019to 31 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients with a peripheral venous catheter in situ, scheduled for elective surgery
Who may be able to join
- Age >18 years undergoing elective surgery with an indwelling peripheral venous catheter.
Who cannot join
- Patients with open wounds in the vicinity of the intravenous line insertion site or scar tissue on the extremity, as well as those with dressings, bandages, or casts on the extremity precluding adequate use of ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Color-flow Doppler to Identify Peripheral Intravenous Catheter Infiltration in Adult Surgical Patients
Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients.
Methods: A prospective study is conducted in adult (>18 years old) patients scheduled to undergo elective surgery. Peripheral intravenous catheter position is evaluated with standard clinical techniques (free flow of fluid from a hanging bag, easy saline injection, and aspiration of blood), and with color flow Doppler ultrasound proximal to the insertion site. Comparative test performance is carried out.
Read the detailed description
Confirmation of adequate peripheral intravenous catheter placement should be determined before using the parenteral route; however, there is no gold standard universally accepted for this purpose. Determination of the correct position of freshly inserted peripheral intravenous catheters and already established intravenous lines depends largely on subjective clinical signs such as visual evidence of swelling around the insertion site, low resistance to infusion and free back-flow of blood. Ultrasound-guided cannulation of peripheral veins has gained popularity in recent years and is standard of practice in some institutions. Primarily used in guiding central line placement, the applications of ultrasound for vascular access continue to expand in the perioperative setting, thanks to its easy use, non-invasiveness and safety profile. On the other hand, utilization of color Doppler technology with flow injection test has been shown to be a valuable tool for early recognition of malfunctioning intravenous catheters. The color Doppler flow technique is both safe and reliable, and aids in identification of correct intravascular position of venous catheters in children.
This study aims to test the hypothesis that the color Doppler flow technique is superior to standard clinical techniques (free flow from a hanging intravenous fluid bag, aspiration of venous blood with syringe, and non-obstructed hand injection of 2 mL of normal saline) to detect the correct position of peripheral intravenous catheters in adult surgical patients.
- Conditions
- Extravasation, Vein Injury
- Being tested
- Color flow doppler
- Keywords
- Color flow Doppler, infiltration, extravasation, peripheral intravenous catheters, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color flow dopplerDiagnostic test
Color flow doppler proximal to vein insertion site to document flow
| Study group | Role | What they receive |
|---|---|---|
| Peripheral IV | Patients with peripheral intravenous line in place undergoing elective surgery Receives: Diagnostic Test: Color flow doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravascular catheter position
Confirmation of adequate position of peripheral vein catheter confirmed by color flow Doppler
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start30 Mar 2019
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtravasationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889678
- Sponsor's protocol ID
- 1237593
- Status last verified
- Jun 2019
- First submitted
- 22 Mar 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Color-flow Doppler to Identify Peripheral Intravenous Catheter Infiltration in Adult Surgical Patients
- ClinicalTrials.gov ID
- NCT03889678
- Acronym / sponsor ID
- 1237593
- Conditions
- Extravasation, Vein Injury
- Keywords
- Color flow Doppler, infiltration, extravasation, peripheral intravenous catheters, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Mar 2019 (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.
Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients.
Methods: A prospective study is conducted in adult (>18 years old) patients scheduled to undergo elective surgery. Peripheral intravenous catheter position is evaluated with standard clinical techniques (free flow of fluid from a hanging bag, easy saline injection, and aspiration of blood), and with color flow Doppler ultrasound proximal to the insertion site. Comparative test performance is carried out.
Detailed description
Confirmation of adequate peripheral intravenous catheter placement should be determined before using the parenteral route; however, there is no gold standard universally accepted for this purpose. Determination of the correct position of freshly inserted peripheral intravenous catheters and already established intravenous lines depends largely on subjective clinical signs such as visual evidence of swelling around the insertion site, low resistance to infusion and free back-flow of blood. Ultrasound-guided cannulation of peripheral veins has gained popularity in recent years and is standard of practice in some institutions. Primarily used in guiding central line placement, the applications of ultrasound for vascular access continue to expand in the perioperative setting, thanks to its easy use, non-invasiveness and safety profile. On the other hand, utilization of color Doppler technology with flow injection test has been shown to be a valuable tool for early recognition of malfunctioning intravenous catheters. The color Doppler flow technique is both safe and reliable, and aids in identification of correct intravascular position of venous catheters in children.
This study aims to test the hypothesis that the color Doppler flow technique is superior to standard clinical techniques (free flow from a hanging intravenous fluid bag, aspiration of venous blood with syringe, and non-obstructed hand injection of 2 mL of normal saline) to detect the correct position of peripheral intravenous catheters in adult surgical patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral IV | – | Diagnostic Test: Color flow dopplerPatients with peripheral intravenous line in place undergoing elective surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with a peripheral venous catheter in situ, scheduled for elective surgery
Key inclusion criteria (1 listed)
- Age >18 years undergoing elective surgery with an indwelling peripheral venous catheter.
Key exclusion criteria (1 listed)
- Patients with open wounds in the vicinity of the intravenous line insertion site or scar tissue on the extremity, as well as those with dressings, bandages, or casts on the extremity precluding adequate use of ultrasound.
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 |
|---|---|---|
| Color flow dopplerColor flow doppler proximal to vein insertion site to document flow | Diagnostic test | Peripheral IV |
Primary outcome
Intravascular catheter position
Time frame: 2 minutes
Confirmation of adequate position of peripheral vein catheter confirmed by color flow Doppler
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 19 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Extravasation and Vein Injury, run by Augusta University 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: finished, as of the sponsor's last update on 19 Jun 2019. 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 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?
Intravascular catheter position (time frame: 2 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 19 Jun 2019.