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Trial record 20 of 577 for:    CARBON DIOXIDE AND anesthesia

Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

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ClinicalTrials.gov Identifier: NCT01219322
Recruitment Status : Unknown
Verified October 2010 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : October 13, 2010
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Sheba Medical Center

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
General Anesthesia Drug: Sodium bicarbonate Drug: normal saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. change in end-tidal carbon dioxide [ Time Frame: 0.5-2 minutes ]
    intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219322


Contacts
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Contact: Ilan keidan, MD 972-3-530-2754 ilan.keidan@sheba.health.gov.il
Contact: Haim Berkenstadt, MD 972-3-530-2754 haim.berkenstadt@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52361
Contact: Ilan Keidan, MD    972-3-530-2754    ilan.keidan@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Ilan Keidan, director of pediatric anesthesiology and pain service, Sheba Medical center, Israel, Sheba Medical Center, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01219322     History of Changes
Other Study ID Numbers: SHEBA-09-7458-IK-CTIL
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010
Keywords provided by Sheba Medical Center:
general endotracheal anesthesia
ASA I or II