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

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.

Study Overview

• Status: Unknown
• Conditions: Extravasation; Infiltration
• Intervention / Treatment: Drug: sodium bicarbonate 4.2%; Drug: diluted sodium bicarbonate 2.1%; Drug: normal saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • 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: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I,II
• no cardiovascular or respiratory disease

Exclusion Criteria:

• ASA > II
• Cardiovascular disease
• Respiratory disease
• renal failure
• metabolic alkalosis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sodium bicarbonate 4.2%; sodium bicarbonate 4.2% 50 m"l	Drug: sodium bicarbonate 4.2%; diluted sodium bicarbonate 50 ml
Experimental: sodium bicarbonate 2.1%; sodium bicarbonate 2.1% 1 50 m"l	Drug: diluted sodium bicarbonate 2.1%; 50ml; Other Names: sodium bicarbonate 2.1%
Placebo Comparator: normal saline; 50 m"l normal saline	Drug: normal saline; 50ml

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Publications and helpful links

General Publications

• Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.
• Keidan I, Sidi A, Ben-Menachem E, Derazne E, Berkenstadt H. A simple diagnostic test to confirm correct intravascular placement of peripheral catheters in order to avoid extravasation. J Clin Anesth. 2015 Nov;27(7):585-8. doi: 10.1016/j.jclinane.2015.07.004. Epub 2015 Aug 15.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: October 9, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 30, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: infiltration; extravasation
• Other Study ID Numbers: SHEBA-11-8716-IK-CTIL