Clinical trial NCT04268225: Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.
Official title: Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Venous Cannulation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 90
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Invasively ventilated
2. Younger than 18 years
3. Peripheral venous access required
4. Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access)

Exclusion Criteria:

1. Refusal to consent
2. Research staff not available

Primary outcomes:
measure: Success of peripheral IV cannulation on first attempt
timeFrame: 10 minutes
Secondary outcomes:
measure: Overall peripheral IV cannulation success rate
timeFrame: 10 minutes
measure: Time to successful peripheral IV cannulation
timeFrame: up to 10 minutes
measure: Number of attempts to success
timeFrame: up to 10 minutes
measure: Inserted cannula diameter
timeFrame: up to 10 minutes
Other outcomes:
measure: Patient age
timeFrame: 1 day (At the time of peripheral IV cannulation)
measure: Patient sex
timeFrame: 1 day (At the time of peripheral IV cannulation)
measure: Patient body mass index (BMI)
timeFrame: 1 day (At the time of peripheral IV cannulation)
measure: Patient inotropic and vasoactive support
timeFrame: 1 day (At the time of peripheral IV cannulation)
measure: Admission-cannulation time
timeFrame: 1 day (At the time of peripheral IV cannulation)
measure: Reason for admission
timeFrame: 1 day (At the time of peripheral IV cannulation)
Locations:
Study officials:
affiliation: Rabin Medical Center
name: Avichai Weissbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Doniger 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.
citation: Otani 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.
citation: Vinograd 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.
citation: Elkhunovich 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.
citation: Benkhadra 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.
citation: Kiberenge 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.
citation: Liu 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.
citation: Takeshita 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.
citation: Takeshita 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.
citation: Takeshita 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.