Difficult Intravenous Access in PediatricsUSgIVNCT02125552
Ultrasound Guided IV Access in a Pediatric Emergency Department
A study testing Ultrasound guidance and Traditional intravenous access in people with Difficult Intravenous Access in Pediatrics, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Difficult Intravenous Access in Pediatrics
- What is being tested?
- Ultrasound guidance and Traditional intravenous access
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2017
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Emergency department patients ages 0-18 years
- Requiring IV access as determined by emergency department attending physician
- Predicted difficult IV access as defined by a revised DIVA score >3
Who cannot join
- Unstable patients triaged as a Level 1 triage acuity
- Patients who refuse IV access
- Non-English speaking parent/guardian
- No study team member available to enroll patient
- Parent/guardian does not consent
- Allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
Read the detailed description
The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale. Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access. If randomized to ultrasound guided IV access, the IV will be placed under direct visualization. Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement. The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.
- Being tested
- Ultrasound guidance, Traditional intravenous access
- Keywords
- vascular access device, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guidanceProcedure or surgery
The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
Traditional intravenous accessProcedure or surgery
Also called Standard of Care arm
Placement by experienced nurse using standard IV techniques
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided intravenous access | Experimental | This group will have their IV placed by ultrasound guidance. Receives: Procedure: Ultrasound guidance |
| Traditional intravenous access | Placebo comparator | The patients randomized to traditional IV access will have their IVs placed by standard technique. Receives: Procedure: Traditional intravenous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Initial IV Placement Attempt
Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.
Measured: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary outcomes (4)
Measure the overall number of IV attempts..
We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.
Measured: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Time to IV access.
The time from enrollment until successful IV access is obtained will be measured.
Measured: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Patient & family satisfaction with IV placement method.
A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.
Measured: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Compare the survival (in length of time) of IV access
We will track the IVs placed as part of the study through the electronic medical record to determine when and why they were removed and if there were any associated complications.
Measured: Participants will be followed through the duration of hospital stay, expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion2 Dec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Difficult Intravenous Access in PediatricsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph J Zorc, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125552
- Sponsor's protocol ID
- 13-010758
- Acronym
- USgIV
- Status last verified
- May 2018
- First submitted
- 24 Apr 2014
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fein JA, Callahan JM, Boardman CR, Gorelick MH. Predicting the need for topical anesthetic in the pediatric emergency department. Pediatrics. 1999 Aug;104(2):e19. doi: 10.1542/peds.104.2.e19.
PubMed 10429137Frey AM. Success rates for peripheral i.v. insertion in a children's hospital. Financial implications. J Intraven Nurs. 1998 May-Jun;21(3):160-5.
PubMed 9652275Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
PubMed 18347490Riker MW, Kennedy C, Winfrey BS, Yen K, Dowd MD. Validation and refinement of the difficult intravenous access score: a clinical prediction rule for identifying children with difficult intravenous access. Acad Emerg Med. 2011 Nov;18(11):1129-34. doi: 10.1111/j.1553-2712.2011.01205.x.
PubMed 22092893Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
PubMed 19262420Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
PubMed 10577399Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.
PubMed 22795988Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.
PubMed 19836193Dargin JM, Rebholz CM, Lowenstein RA, Mitchell PM, Feldman JA. Ultrasonography-guided peripheral intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 2010 Jan;28(1):1-7. doi: 10.1016/j.ajem.2008.09.001.
PubMed 20006193Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12.
PubMed 22409596Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.
PubMed 23415740Bair AE, Rose JS, Vance CW, Andrada-Brown E, Kuppermann N. Ultrasound-assisted peripheral venous access in young children: a randomized controlled trial and pilot feasibility study. West J Emerg Med. 2008 Nov;9(4):219-24.
PubMed 19561750Aponte H, Acosta S, Rigamonti D, Sylvia B, Austin P, Samolitis T. The use of ultrasound for placement of intravenous catheters. AANA J. 2007 Jun;75(3):212-6.
PubMed 17591303Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
PubMed 19371518Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.
PubMed 16271677
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT02125552
- Acronym / sponsor ID
- USgIV / 13-010758
- Keywords
- vascular access device, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Apr 2014 (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.
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
Detailed description
The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale. Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access. If randomized to ultrasound guided IV access, the IV will be placed under direct visualization. Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement. The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided intravenous access | Experimental | Procedure: Ultrasound guidanceThis group will have their IV placed by ultrasound guidance. |
| Traditional intravenous access | Placebo comparator | Procedure: Traditional intravenous accessThe patients randomized to traditional IV access will have their IVs placed by standard technique. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Emergency department patients ages 0-18 years
- Requiring IV access as determined by emergency department attending physician
- Predicted difficult IV access as defined by a revised DIVA score >3
Key exclusion criteria (6 listed)
- Unstable patients triaged as a Level 1 triage acuity
- Patients who refuse IV access
- Non-English speaking parent/guardian
- No study team member available to enroll patient
- Parent/guardian does not consent
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 guidanceThe ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group | Procedure or surgery | Ultrasound guided intravenous access |
| Traditional intravenous accessAlso: Standard of Care armPlacement by experienced nurse using standard IV techniques | Procedure or surgery | Traditional intravenous access |
Primary outcome
Success of Initial IV Placement Attempt
Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.
4 secondary outcomes
Measure the overall number of IV attempts..
Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Time to IV access.
Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Patient & family satisfaction with IV placement method.
Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Compare the survival (in length of time) of IV access
Time frame: Participants will be followed through the duration of hospital stay, expected average of 5 days
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 15 May 2018.
- Background: PubMed 10429137Fein JA, Callahan JM, Boardman CR, Gorelick MH. Predicting the need for topical anesthetic in the pediatric emergency department. Pediatrics. 1999 Aug;104(2):e19. doi: 10.1542/peds.104.2.e19.
- Background: PubMed 9652275Frey AM. Success rates for peripheral i.v. insertion in a children's hospital. Financial implications. J Intraven Nurs. 1998 May-Jun;21(3):160-5.
- Background: PubMed 18347490Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
- Background: PubMed 22092893Riker MW, Kennedy C, Winfrey BS, Yen K, Dowd MD. Validation and refinement of the difficult intravenous access score: a clinical prediction rule for identifying children with difficult intravenous access. Acad Emerg Med. 2011 Nov;18(11):1129-34. doi: 10.1111/j.1553-2712.2011.01205.x.
- Background: PubMed 19262420Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
- Background: PubMed 10577399Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
- Background: PubMed 22795988Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.
- Background: PubMed 19836193Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.
- Background: PubMed 20006193Dargin JM, Rebholz CM, Lowenstein RA, Mitchell PM, Feldman JA. Ultrasonography-guided peripheral intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 2010 Jan;28(1):1-7. doi: 10.1016/j.ajem.2008.09.001.
- Background: PubMed 22409596Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12.
- Background: PubMed 23415740Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.
- Background: PubMed 19561750Bair AE, Rose JS, Vance CW, Andrada-Brown E, Kuppermann N. Ultrasound-assisted peripheral venous access in young children: a randomized controlled trial and pilot feasibility study. West J Emerg Med. 2008 Nov;9(4):219-24.
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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.
Joseph J Zorc, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guidance and Traditional intravenous access in people with Difficult Intravenous Access in Pediatrics, run by Children's Hospital of Philadelphia 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 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 15 May 2018. 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. Some participants in this study may receive a placebo. 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?
Success of Initial IV Placement Attempt (time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02125552, which also lists 19 linked publications.
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 15 May 2018.