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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

Phase 1
Completed
Conditions
Verifying the Correct Position of Intravenous Catheters
Interventions
Device: intravenous sodium bicarbonate
Registration Number
NCT01409083
Lead Sponsor
Sheba Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria
  • ASA I,II
  • age 2-8 years
Exclusion Criteria
  • ASA III or higher

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
intravenous bicarbonateintravenous sodium bicarbonateDiluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2
controlintravenous sodium bicarbonateequal volume of normal saline will be randomely injected
Primary Outcome Measures
NameTimeMethod
increase in exhaled carbon dioxide0.5-10.00 seconds
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sheba Medical Center

🇮🇱

Ramat Gan, Israel

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