Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

General Anesthesia Clinical Trial

Official title:

Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01219322
• Other study ID #: SHEBA-09-7458-IK-CTIL
• Status: Unknown status
• Phase: Phase 1
• First received: October 10, 2010
• Last updated: October 27, 2010
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2010
• Source: Sheba Medical Center
• Contact: Ilan keidan, MD
• Phone: 972-3-530-2754
• Email: ilan.keidan[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.

Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers

Exclusion Criteria:

• respiratory disease

• active smoking

• cardiovascular disease

• renal disease

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• Sodium bicarbonate
single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc
• normal saline
intravenous normal saline volume equivalent to sodium bicarbonate

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in end-tidal carbon dioxide	intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes	0.5-2 minutes