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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children

NCT ID: NCT01219322

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Keywords

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general endotracheal anesthesia ASA I or II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intravenous bicarbonate

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

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

intravenous normal saline volume equivalent to sodium bicarbonate

Interventions

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Sodium bicarbonate

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

Intervention Type DRUG

normal saline

intravenous normal saline volume equivalent to sodium bicarbonate

Intervention Type DRUG

Other Intervention Names

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8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* respiratory disease
* active smoking
* cardiovascular disease
* renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center, Department of Anesthesiology

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ilan keidan, MD

Role: CONTACT

Phone: 972-3-530-2754

Email: [email protected]

Haim Berkenstadt, MD

Role: CONTACT

Phone: 972-3-530-2754

Email: [email protected]

Facility Contacts

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Ilan Keidan, MD

Role: primary

Other Identifiers

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SHEBA-09-7458-IK-CTIL

Identifier Type: -

Identifier Source: org_study_id