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

Sheba Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Infiltration; Extravasation

Treatments: Drug: diluted sodium bicarbonate 2.1%; Drug: sodium bicarbonate 4.2%; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01458873

SHEBA-11-8716-IK-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I,II
• no cardiovascular or respiratory disease

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

20 participants in 3 patient groups, including a placebo group

sodium bicarbonate 4.2%

Experimental group

Description:

sodium bicarbonate 4.2% 50 m"l

Treatment:

Drug: sodium bicarbonate 4.2%

sodium bicarbonate 2.1%

Experimental group

Description:

sodium bicarbonate 2.1% 1 50 m"l

Treatment:

Drug: diluted sodium bicarbonate 2.1%

normal saline

Placebo Comparator group

Description:

50 m"l normal saline

Treatment:

Drug: normal saline