Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Verifying the Correct Position of Intravenous Catheters |
Device: intravenous sodium bicarbonate |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Diagnostic |
| Official Title: | Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children |
- increase in exhaled carbon dioxide [ Time Frame: 0.5-10.00 seconds ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | July 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: intravenous bicarbonate
Diluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2
|
Device: intravenous sodium bicarbonate
Dilted sodium bicarbonate 2.1%
|
|
Placebo Comparator: control
equal volume of normal saline will be randomely injected
|
Device: intravenous sodium bicarbonate
Dilted sodium bicarbonate 2.1%
|
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.
Eligibility| Ages Eligible for Study: | 2 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA I,II
- age 2-8 years
Exclusion Criteria:
- ASA III or higher
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Ilan Keidan, director of pediatric anesthesia, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01409083 History of Changes |
| Other Study ID Numbers: | SHEBA-11-8207-IK-CTIL |
| Study First Received: | August 2, 2011 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Sheba Medical Center:
|
infiltration extravasation end-tidal carbon dioxide sodium bicarbonate |
ClinicalTrials.gov processed this record on June 18, 2013