Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

This study has been completed.
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dr. Ilan Keidan, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01409083
First received: August 2, 2011
Last updated: December 11, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • ASA I,II
  • age 2-8 years

Exclusion Criteria:

  • ASA III or higher
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409083

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel, 52361
Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University
  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 October 21, 2014