Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Verifying the Correct Position of Intravenous Catheters

Intervention / Treatment
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* Device: intravenous sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I,II age 2-8 years Exclusion Criteria: ASA III or higher

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous bicarbonate<br>Diluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2 | Device: intravenous sodium bicarbonate<br>* Dilted sodium bicarbonate 2.1%<br>|
| Placebo Comparator: control<br>equal volume of normal saline will be randomely injected | Device: intravenous sodium bicarbonate<br>* Dilted sodium bicarbonate 2.1%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in exhaled carbon dioxide |  | 0.5-10.00 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltration, extravasation, end-tidal carbon dioxide, sodium bicarbonate