Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

Verifying the Correct Position of Intravenous Catheters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409083
• Other study ID #: SHEBA-11-8207-IK-CTIL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 2, 2011
• Last updated: December 11, 2012
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• ASA I,II

• age 2-8 years

Exclusion Criteria:

• ASA III or higher

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Verifying the Correct Position of Intravenous Catheters

Intervention

Device:
• intravenous sodium bicarbonate
Dilted sodium bicarbonate 2.1%

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in exhaled carbon dioxide		0.5-10.00 seconds	No