Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

NCT01219322 | Unknown Phase 1

• 1 other identifier: SHEBA-09-7458-IK-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Keywords

general endotracheal anesthesia; ASA I or II

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intravenous bicarbonate

EXPERIMENTAL

Intravenous bicarbonate(05meq/cc ) 50 cc will be injected.

Drug: Sodium bicarbonate

Intravenous injection of 50 cc normal saline

PLACEBO COMPARATOR

Injection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug

Drug: normal saline

Interventions

Sodium bicarbonate DRUG

single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc

Also known as: 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.

intravenous bicarbonate

normal saline DRUG

intravenous normal saline volume equivalent to sodium bicarbonate

Intravenous injection of 50 cc normal saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• respiratory disease
• active smoking
• cardiovascular disease
• renal disease

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52361, Israel

RECRUITING

MeSH Terms

Interventions

Sodium Bicarbonate; Saline Solution

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ilan keidan, MD

CONTACT

972-3-530-2754; ilan.keidan@sheba.health.gov.il

Haim Berkenstadt, MD

CONTACT

972-3-530-2754; haim.berkenstadt@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 10, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

IL (1)