Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01409083
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2011-08-02
Brief Title:
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cathetersOnce 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
This study is conducted to access the clinical application of measuring exhaled carbon dioxide to verify the correct position of intravenous cathetersOnce 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 84 1 meqmL sodium bicarbonate mixed in a 13 ratio with sterile water to achieve a final diluted concentration of 21 025 mEqmL In 20 ASA I-II mechanically ventilated children age 2-8 years the effects of 1 mlkg of diluted 21 sodium bicarbonate or 09 normal salineinjected 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None