Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

Study Overview
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Brief Summary
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Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Detailed Description
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Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response. The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Official Title
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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

Conditions
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Infiltration, Extravasation

Intervention / Treatment
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* Drug: sodium bicarbonate 4.2%
* Drug: diluted sodium bicarbonate 2.1%
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I,II no cardiovascular or respiratory disease Exclusion Criteria: ASA > II Cardiovascular disease Respiratory disease renal failure metabolic alkalosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium bicarbonate 4.2%<br>sodium bicarbonate 4.2% 50 ml | Drug: sodium bicarbonate 4.2%<br>* diluted sodium bicarbonate 50 ml<br>|
| Experimental: sodium bicarbonate 2.1%<br>sodium bicarbonate 2.1% 1 50 ml | Drug: diluted sodium bicarbonate 2.1%<br>* 50ml<br>* Other names: sodium bicarbonate 2.1%;|
| Placebo Comparator: normal saline<br>50 ml normal saline | Drug: normal saline<br>* 50ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transient increase in end tidal carbon dioxide | Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline | 4-12 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in venous blood pH | Blood pH and will be measured prior and ten minutes after the injections | 10-20 minutes | 
| Subjective adverse symptoms associated with injection of sodium bicarbonate | The subjective symptoms as well as hemodynamic changes associated with the injection of sodium bicarbonate will be recorded | 1 minute | 
| change in venous blood sodium | blood sodium level will be measured before and 10-20 minutes after the end of the injections. | 10- 20 minutes | 
| change in venous blood bicarbonate level | blood level of bicarbonate will be measured before and 10-20 minutes after the injection. | 10-20 minutes | 
| change in venous blood potasium level | venous blood potasium level will be measured before and 10-20 minutes after injection | 10-20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltration, extravasation