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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01219322
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
8
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium bicarbonate
  • Drug: normal saline
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Diagnostic
Official Title:
Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter
Study Start Date :
Oct 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2011
Anticipated Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: intravenous bicarbonate

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

Drug: Sodium bicarbonate
single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc
Other Names:
  • 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.

    		•
    Placebo Comparator: Intravenous injection of 50 cc normal saline

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

    Drug: normal saline
    intravenous normal saline volume equivalent to sodium bicarbonate

    Outcome Measures

    Primary Outcome Measures

    1. change in end-tidal carbon dioxide [0.5-2 minutes]

      intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers
    Exclusion Criteria:

    • respiratory disease

    • active smoking

    • cardiovascular disease

    • renal disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Tel Hashomer Israel 52361

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01219322
    Other Study ID Numbers:
    • SHEBA-09-7458-IK-CTIL
    First Posted:
    Oct 13, 2010
    Last Update Posted:
    Oct 28, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    general endotracheal anesthesia
    ASA I or II

    Study Results

    No Results Posted as of Oct 28, 2010