Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue

Detailed Description
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The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients. each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria). Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories: IV in place ready to use for chemotherapy ( good blood return) Doubtful position ( no blood return/ little blood return bu flushes well). IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections

Official Title
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Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate

Conditions
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Detection of the Correct Position of Intravenous Line

Intervention / Treatment
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* Drug: sodium bicarbonate 4.2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 oncological disease requires intravenous chemotherapy Exclusion Criteria: 1. refusal to participate 2. lung disease acute or chronic sPo2 < 92%, PaCO2 > 50 3. renal failure Creatinine > 2 mg% 4. metabolic alkalosis HCO3 > 30 meq/L 5. medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid 6. obesity BMI > 38 7. congestive heart failure EF < 40 % or clinical signs of congestive heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV bicarbonate 4.2% 20 cc<br>injecting 20cc 4.2% to a newly administered IV line | Drug: sodium bicarbonate 4.2%<br> <br> |
| Placebo Comparator: IV normal saline<br>injecting 20 cc normal saline to a newly administered IV line | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in exhaled end tidal co2 | the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2 | 1-3 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capnography, infiltration, extravasation, sodium bicarbonate, end tidal carbon dioxide, chemotherapy