Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children
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|ClinicalTrials.gov Identifier: NCT01219322|
Recruitment Status : Unknown
Verified October 2010 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : October 13, 2010
Last Update Posted : October 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|General Anesthesia||Drug: Sodium bicarbonate Drug: normal saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2011|
Experimental: intravenous bicarbonate
Intravenous bicarbonate(05meq/cc ) 50 cc will be injected.
Drug: Sodium bicarbonate
single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc
Other Name: 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.
Placebo Comparator: Intravenous injection of 50 cc normal saline
Injection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug
Drug: normal saline
intravenous normal saline volume equivalent to sodium bicarbonate
- change in end-tidal carbon dioxide [ Time Frame: 0.5-2 minutes ]intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219322
|Contact: Ilan keidan, MDemail@example.com|
|Contact: Haim Berkenstadt, MDfirstname.lastname@example.org|
|Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel, 52361|
|Contact: Ilan Keidan, MD 972-3-530-2754 email@example.com|