Extravasation, Infiltration
Conditions
Keywords
infiltration, extravasation
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.
Interventions
diluted sodium bicarbonate 50 ml
DRUGdiluted sodium bicarbonate 2.1%
50ml
DRUGnormal saline
50ml
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA I,II * no cardiovascular or respiratory disease
Exclusion criteria
* ASA \> II * Cardiovascular disease * Respiratory disease * renal failure * metabolic alkalosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Contacts
Primary ContactILAN KEIDAN, MD
Outcome results
None listed