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

Infiltration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01458873
• Other study ID #: SHEBA-11-8716-IK-CTIL
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 9, 2011
• Last updated: October 30, 2011
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: Sheba Medical Center
• Contact: ILAN KEIDAN, MD
• Phone: 972-3-5302754
• Email: ilan.keidan[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA I,II

• no cardiovascular or respiratory disease

Exclusion Criteria:

• ASA > II

• Cardiovascular disease

• Respiratory disease

• renal failure

• metabolic alkalosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Extravasation
• Infiltration

Intervention

Drug:
• sodium bicarbonate 4.2%
diluted sodium bicarbonate 50 ml
• diluted sodium bicarbonate 2.1%
50ml
• normal saline
50ml

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in venous blood pH	Blood pH and will be measured prior and ten minutes after the injections	10-20 minutes	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	change in venous blood bicarbonate level	blood level of bicarbonate will be measured before and 10-20 minutes after the injection.	10-20 minutes	Yes
Secondary	change in venous blood potasium level	venous blood potasium level will be measured before and 10-20 minutes after injection	10-20 minutes	Yes