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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01409083
Enrollment
18
Registered
2011-08-03
Start date
2011-07-31
Completion date
2012-12-31
Last updated
2012-12-12

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

Conditions

Verifying the Correct Position of Intravenous Catheters

Keywords

infiltration, extravasation, end-tidal carbon dioxide, sodium bicarbonate

Brief summary

Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide in the lungs. This study is conducted to access the clinical application of measuring exhaled carbon dioxide to verify the correct position of intravenous catheters.Once the catheter is in the correct position the injected bicarbonate will be detected as a distinct elevation of exhaled carbon dioxide. A similar study was already performed in adults and was found useful. The investigators now extend the clinical application to children.

Detailed description

Extravasation is the unintentional injection or leakage of fluids into the perivascular or subcutaneous space resulting in potential tissue injury. This prospective controlled study, will assesse the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of intravenous (IV) catheters in ventilated children. Diluted sodium bicarbonate will be created using undiluted standard 8.4% (1 meq/mL) sodium bicarbonate mixed in a 1:3 ratio with sterile water to achieve a final diluted concentration of 2.1% (0.25 mEq/mL). In 20 ASA I-II mechanically ventilated children age 2-8 years, the effects of 1 ml/kg of diluted 2.1% sodium bicarbonate or 0.9% normal saline,injected in a randomized order, will be analyzed. All children will have venous blood samples taken prior to injection and 10 minutes after injection for analysis of venous blood pH and electrolytes.

Interventions

Dilted sodium bicarbonate 2.1%

Sponsors

Tel Aviv University
CollaboratorOTHER
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* ASA I,II * age 2-8 years

Exclusion criteria

* ASA III or higher

Design outcomes

Primary

MeasureTime frame
increase in exhaled carbon dioxide0.5-10.00 seconds

Countries

Israel

Outcome results

None listed

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