Peripheral Venous CannulationNCT04268225
Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.
A study testing US guided dynamic needle tip positioning peripheral intravenous cannulation and Traditional peripheral intravenous cannulation in people with Peripheral Venous Cannulation, run by Rabin Medical Center.
Trial summary
This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Peripheral Venous Cannulation
- What is being tested?
- US guided dynamic needle tip positioning peripheral intravenous cannulation and Traditional peripheral intravenous cannulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2022
- 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
- Invasively ventilated
- Younger than 18 years
- Peripheral venous access required
- Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access)
Who cannot join
- Refusal to consent
- Research staff not available
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.
This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and mechanically ventilated pediatric intensive care unit (PICU) patients. First attempt success rate, overall success rate within 3 attempts or 10 minutes (whichever comes first), number of attempts to success, time to success and cannula sizes will be compared between the 2 techniques. The study will include intubated, sedated and mechanically ventilated children, aged 0-18 years, hospitalized in the PICU who require peripheral intravenous (PIV) access for their management.
- Conditions
- Peripheral Venous Cannulation
- Being tested
- US guided dynamic needle tip positioning peripheral intravenous cannulation, Traditional peripheral intravenous cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided dynamic needle tip positioning peripheral intravenous cannulationProcedure or surgery
Catheterizations will be performed by one of three pediatric intensivists with vast experience in both traditional and US guided DNTP techniques for peripheral intravenous access. The operator will be allowed to independently choose which peripheral vein to cannulate. If necessary, patients will be given supplemental dose of sedation and analgesia in addition to the already given continuous infusions for invasive mechanical ventilation. Before puncture, the limb will be taped and maintained in an optimal position. A tourniquet will be placed proximal to the planned cannulation site. The site of puncture will be disinfected with Chlorhexidine gluconate 0.5% w/v, Alcohol 70% v/v. The choice of catheter will be left to the discretion of the operator. Available PIV cannulas include : 14 GA, 2X45 mm; 17 GA, 1.4X45 mm; 18 GA 1.2X45 mm; 20 GA 1X32mm BD Venflon™ and 24 GA, 0.7X19 mm; 26 GA 0.6X19 mm BD Neoflon™ (Becton Dickinson Infusion Therapy AB, Helsingborg, Sweden).
Traditional peripheral intravenous cannulationProcedure or surgery
For traditional insertion technique insertion attempt will be blind or tactile.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Dynamic Needle Tip Positioning Technique | Experimental | In this arm the US transducer, protected with a sterile cover and sterile gel will be placed in the short axis above the distal end of the selected vein, moving the probe to place the vein in the center of the ultrasound screen under the middle mark of the image. The catheter needle will be inserted close to the transducer. The needle tip will be visualized as a white dot on the ultrasound screen. Then, the transducer will be shifted slightly proximally until the white dot disappears from the screen. The needle and the transducer will be moved alternately toward the patient several times to visualize the needle tip in real time. After penetrating the anterior wall of the vein, these steps will be repeated a few more times with a smaller insertion angle to visualize the white dot in the vein. Finally, the outer catheter will be fully advanced and the needle core will be extracted. Receives: Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation |
| Traditional insertion group | Active comparator | For traditional insertion technique insertion attempt will be blind or tactile. Otherwise, the same protocol and measurements as elaborated for the US guided group will be applied. Receives: Procedure: Traditional peripheral intravenous cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of peripheral IV cannulation on first attempt
Assessment of peripheral IV cannulation success on first attempt (Yes vs No)
Measured: 10 minutes
Secondary outcomes (4)
Overall peripheral IV cannulation success rate
The overall success rate of peripheral intravenous cannulation within 3 attempts.
Measured: 10 minutes
Time to successful peripheral IV cannulation
Defined as the time from first skin puncture to successful cannulation (minutes).
Measured: up to 10 minutes
Number of attempts to success
Number of puncture attempts (1,2 or 3) needed for achieving a a successful cannulation
Measured: up to 10 minutes
Inserted cannula diameter
Cannula diameter (in GA) successfully inserted
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral Venous CannulationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avichai Weissbach, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268225
- Sponsor's protocol ID
- 0044-20-RMC
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costantino 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 16271677Doniger 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 19262420Otani T, Morikawa Y, Hayakawa I, Atsumi Y, Tomari K, Tomobe Y, Uda K, Funakoshi Y, Sakaguchi C, Nishimoto S, Hataya H. Ultrasound-guided peripheral intravenous access placement for children in the emergency department. Eur J Pediatr. 2018 Oct;177(10):1443-1449. doi: 10.1007/s00431-018-3201-3. Epub 2018 Jun 30.
PubMed 29961178Vinograd AM, Zorc JJ, Dean AJ, Abbadessa MKF, Chen AE. First-Attempt Success, Longevity, and Complication Rates of Ultrasound-Guided Peripheral Intravenous Catheters in Children. Pediatr Emerg Care. 2018 Jun;34(6):376-380. doi: 10.1097/PEC.0000000000001063.
PubMed 28221281Elkhunovich M, Barreras J, Bock Pinero V, Ziv N, Vaiyani A, Mailhot T. The use of ultrasound for peripheral IV placement by vascular access team nurses at a tertiary children's hospital. J Vasc Access. 2017 Jan 18;18(1):57-63. doi: 10.5301/jva.5000615. Epub 2016 Nov 15.
PubMed 27886365Benkhadra 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 22409596Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.
PubMed 29135593Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
PubMed 29787409Takeshita J, Inata Y, Ito Y, Nishiyama K, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Placement of a Peripherally Inserted Central Catheter in Pediatric Patients. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):114-118. doi: 10.1053/j.jvca.2019.04.029. Epub 2019 May 2.
PubMed 31129072Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.
PubMed 30638922Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Superiority of Dynamic Needle Tip Positioning for Ultrasound-Guided Peripheral Venous Catheterization in Patients Younger Than 2 Years Old: A Randomized Controlled Trial. Pediatr Crit Care Med. 2019 Sep;20(9):e410-e414. doi: 10.1097/PCC.0000000000002034.
PubMed 31232853
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.
- ClinicalTrials.gov ID
- NCT04268225
- Acronym / sponsor ID
- 0044-20-RMC
- Conditions
- Peripheral Venous Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Feb 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.
This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and mechanically ventilated pediatric intensive care unit (PICU) patients. First attempt success rate, overall success rate within 3 attempts or 10 minutes (whichever comes first), number of attempts to success, time to success and cannula sizes will be compared between the 2 techniques. The study will include intubated, sedated and mechanically ventilated children, aged 0-18 years, hospitalized in the PICU who require peripheral intravenous (PIV) access for their management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Dynamic Needle Tip Positioning Technique | Experimental | Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulationIn this arm the US transducer, protected with a sterile cover and sterile gel will be placed in the short axis above the distal end of the selected vein, moving the probe to place the vein in the center of the ultrasound screen under the middle mark of the image. The catheter needle will be inserted close to the transducer. The needle tip will be visualized as a white dot on the ultrasound screen. Then, the transducer will be shifted slightly proximally until the white dot disappears from the screen. The needle and the transducer will be moved alternately toward the patient several times to visualize the needle tip in real time. After penetrating the anterior wall of the vein, these steps will be repeated a few more times with a smaller insertion angle to visualize the white dot in the vein. Finally, the outer catheter will be fully advanced and the needle core will be extracted. |
| Traditional insertion group | Active comparator | Procedure: Traditional peripheral intravenous cannulationFor traditional insertion technique insertion attempt will be blind or tactile. Otherwise, the same protocol and measurements as elaborated for the US guided group will be applied. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Invasively ventilated
- Younger than 18 years
- Peripheral venous access required
- Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access)
Key exclusion criteria (2 listed)
- Refusal to consent
- Research staff not available
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 |
|---|---|---|
| US guided dynamic needle tip positioning peripheral intravenous cannulationCatheterizations will be performed by one of three pediatric intensivists with vast experience in both traditional and US guided DNTP techniques for peripheral intravenous access. The operator will be allowed to independently choose which peripheral vein to cannulate. If necessary, patients will be given supplemental dose of sedation and analgesia in addition to the already given continuous infusions for invasive mechanical ventilation. Before puncture, the limb will be taped and maintained in an optimal position. A tourniquet will be placed proximal to the planned cannulation site. The site of puncture will be disinfected with Chlorhexidine gluconate 0.5% w/v, Alcohol 70% v/v. The choice of catheter will be left to the discretion of the operator. Available PIV cannulas include : 14 GA, 2X45 mm; 17 GA, 1.4X45 mm; 18 GA 1.2X45 mm; 20 GA 1X32mm BD Venflon™ and 24 GA, 0.7X19 mm; 26 GA 0.6X19 mm BD Neoflon™ (Becton Dickinson Infusion Therapy AB, Helsingborg, Sweden). | Procedure or surgery | Ultrasound Guided Dynamic Needle Tip Positioning Technique |
| Traditional peripheral intravenous cannulationFor traditional insertion technique insertion attempt will be blind or tactile. | Procedure or surgery | Traditional insertion group |
Primary outcome
Success of peripheral IV cannulation on first attempt
Time frame: 10 minutes
Assessment of peripheral IV cannulation success on first attempt (Yes vs No)
4 secondary outcomes
Overall peripheral IV cannulation success rate
Time frame: 10 minutes
Time to successful peripheral IV cannulation
Time frame: up to 10 minutes
Number of attempts to success
Time frame: up to 10 minutes
Inserted cannula diameter
Time frame: up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 16271677Costantino 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.
- 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 29961178Otani T, Morikawa Y, Hayakawa I, Atsumi Y, Tomari K, Tomobe Y, Uda K, Funakoshi Y, Sakaguchi C, Nishimoto S, Hataya H. Ultrasound-guided peripheral intravenous access placement for children in the emergency department. Eur J Pediatr. 2018 Oct;177(10):1443-1449. doi: 10.1007/s00431-018-3201-3. Epub 2018 Jun 30.
- Background: PubMed 28221281Vinograd AM, Zorc JJ, Dean AJ, Abbadessa MKF, Chen AE. First-Attempt Success, Longevity, and Complication Rates of Ultrasound-Guided Peripheral Intravenous Catheters in Children. Pediatr Emerg Care. 2018 Jun;34(6):376-380. doi: 10.1097/PEC.0000000000001063.
- Background: PubMed 27886365Elkhunovich M, Barreras J, Bock Pinero V, Ziv N, Vaiyani A, Mailhot T. The use of ultrasound for peripheral IV placement by vascular access team nurses at a tertiary children's hospital. J Vasc Access. 2017 Jan 18;18(1):57-63. doi: 10.5301/jva.5000615. Epub 2016 Nov 15.
- 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 29135593Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.
- Background: PubMed 29787409Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
- Background: PubMed 31129072Takeshita J, Inata Y, Ito Y, Nishiyama K, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Placement of a Peripherally Inserted Central Catheter in Pediatric Patients. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):114-118. doi: 10.1053/j.jvca.2019.04.029. Epub 2019 May 2.
- Background: PubMed 30638922Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.
- Background: PubMed 31232853Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Superiority of Dynamic Needle Tip Positioning for Ultrasound-Guided Peripheral Venous Catheterization in Patients Younger Than 2 Years Old: A Randomized Controlled Trial. Pediatr Crit Care Med. 2019 Sep;20(9):e410-e414. doi: 10.1097/PCC.0000000000002034.
- 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.
Avichai Weissbach, MD principal investigator
Rabin Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing US guided dynamic needle tip positioning peripheral intravenous cannulation and Traditional peripheral intravenous cannulation in people with Peripheral Venous Cannulation, run by Rabin Medical Center.
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 4 inclusion and 2 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Avichai Weissbach, MD (+97239253686, weissbac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of peripheral IV cannulation on first attempt (time frame: 10 minutes). 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 NCT04268225, which also lists 11 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 13 Mar 2020.