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Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.

Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04268225
Enrollment
90
Registered
2020-02-13
Start date
2020-03-31
Completion date
2022-03-31
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Venous Cannulation

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.

Interventions

PROCEDUREUS guided dynamic needle tip positioning peripheral intravenous cannulation

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).

PROCEDURETraditional peripheral intravenous cannulation

For traditional insertion technique insertion attempt will be blind or tactile.

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success of peripheral IV cannulation on first attempt10 minutesAssessment of peripheral IV cannulation success on first attempt (Yes vs No)

Secondary

MeasureTime frameDescription
Overall peripheral IV cannulation success rate10 minutesThe overall success rate of peripheral intravenous cannulation within 3 attempts.
Time to successful peripheral IV cannulationup to 10 minutesDefined as the time from first skin puncture to successful cannulation (minutes).
Number of attempts to successup to 10 minutesNumber of puncture attempts (1,2 or 3) needed for achieving a a successful cannulation
Inserted cannula diameterup to 10 minutesCannula diameter (in GA) successfully inserted

Other

MeasureTime frameDescription
Patient age1 day (At the time of peripheral IV cannulation)Age in years
Reason for admission1 day (At the time of peripheral IV cannulation)Medical vs Surgical
Patient sex1 day (At the time of peripheral IV cannulation)Female vs Male
Patient body mass index (BMI)1 day (At the time of peripheral IV cannulation)BMI (in kg/m\^2) for age percentile
Patient inotropic and vasoactive support1 day (At the time of peripheral IV cannulation)Vasoactive-Inotropic Score (VIS score)
Admission-cannulation time1 day (At the time of peripheral IV cannulation)Time from hospital admission to first attempt of cannulation

Contacts

Primary ContactAvichai Weissbach, MD
weissbac@gmail.com+97239253686

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026