Clinical trial NCT01458873: Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
Official title: Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Infiltration
Extravasation
Keywords: infiltration
extravasation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* ASA I,II
* no cardiovascular or respiratory disease

Exclusion Criteria:

* ASA \> II
* Cardiovascular disease
* Respiratory disease
* renal failure
* metabolic alkalosis

Primary outcomes:
measure: transient increase in end tidal carbon dioxide
timeFrame: 4-12 seconds
Secondary outcomes:
measure: Change in venous blood pH
timeFrame: 10-20 minutes
measure: Subjective adverse symptoms associated with injection of sodium bicarbonate
timeFrame: 1 minute
measure: change in venous blood sodium
timeFrame: 10- 20 minutes
measure: change in venous blood bicarbonate level
timeFrame: 10-20 minutes
measure: change in venous blood potasium level
timeFrame: 10-20 minutes
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
citation: 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.
citation: 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.