Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 12, 2012
December 1, 2012
1.4 years
August 2, 2011
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
increase in exhaled carbon dioxide
0.5-10.00 seconds
Study Arms (2)
intravenous bicarbonate
EXPERIMENTALDiluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2
control
PLACEBO COMPARATORequal volume of normal saline will be randomely injected
Interventions
Eligibility Criteria
You may qualify if:
- ASA I,II
- age 2-8 years
You may not qualify if:
- ASA III or higher
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Tel Aviv Universitycollaborator
Study Sites (1)
Sheba Medical Center
Ramat Gan, 52361, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of pediatric anesthesia
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 3, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 12, 2012
Record last verified: 2012-12