Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
- Conditions
- InfiltrationExtravasation
- Interventions
- Drug: sodium bicarbonate 4.2%Drug: diluted sodium bicarbonate 2.1%Drug: normal saline
- Registration Number
- NCT01458873
- Lead Sponsor
- Sheba Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- ASA I,II
- no cardiovascular or respiratory disease
- ASA > II
- Cardiovascular disease
- Respiratory disease
- renal failure
- metabolic alkalosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description sodium bicarbonate 4.2% sodium bicarbonate 4.2% sodium bicarbonate 4.2% 50 m"l sodium bicarbonate 2.1% diluted sodium bicarbonate 2.1% sodium bicarbonate 2.1% 1 50 m"l normal saline normal saline 50 m"l normal saline
- Primary Outcome Measures
Name Time Method transient increase in end tidal carbon dioxide 4-12 seconds Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline
- Secondary Outcome Measures
Name Time Method Change in venous blood pH 10-20 minutes Blood pH and will be measured prior and ten minutes after the injections
Subjective adverse symptoms associated with injection of sodium bicarbonate 1 minute The subjective symptoms as well as hemodynamic changes associated with the injection of sodium bicarbonate will be recorded
change in venous blood sodium 10- 20 minutes blood sodium level will be measured before and 10-20 minutes after the end of the injections.
change in venous blood bicarbonate level 10-20 minutes blood level of bicarbonate will be measured before and 10-20 minutes after the injection.
change in venous blood potasium level 10-20 minutes venous blood potasium level will be measured before and 10-20 minutes after injection
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel Hashomer, Israel