Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter

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.

Study Overview

• Status: Unknown
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Sodium bicarbonate; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52361
    • Recruiting
    • Sheba Medical Center
    • Contact: ilan keidan, MD; Phone Number: 972-3-530-2754; Email: ilan.keidan@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers

Exclusion Criteria:

• respiratory disease
• active smoking
• cardiovascular disease
• renal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: October 10, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 27, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: general endotracheal anesthesia; ASA I or II
• Other Study ID Numbers: SHEBA-09-7458-IK-CTIL