Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

Study Overview
=================
Brief Summary
-----------------
Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients. Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.

Official Title
-----------------
Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Drug: Sodium bicarbonate
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers Exclusion Criteria: respiratory disease active smoking cardiovascular disease renal disease

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous bicarbonate<br>Intravenous bicarbonate(05meq/cc ) 50 cc will be injected. | Drug: Sodium bicarbonate<br>* single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc<br>* Other names: 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.;|
| Placebo Comparator: Intravenous injection of 50 cc normal saline<br>Injection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug | Drug: normal saline<br>* intravenous normal saline volume equivalent to sodium bicarbonate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in end-tidal carbon dioxide | intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes | 0.5-2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
general endotracheal anesthesia, ASA I or II