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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children

NCT ID: NCT01409083

Last Updated: 2012-12-12

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-12-31

Brief Summary

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Sodium bicarbonate injected into a blood vessel transforms to carbon dioxide and water. The increase in carbon dioxide production can be detected by measuring the exhaled carbon dioxide in the lungs.

This study is conducted to access the clinical application of measuring exhaled carbon dioxide to verify the correct position of intravenous catheters.Once the catheter is in the correct position the injected bicarbonate will be detected as a distinct elevation of exhaled carbon dioxide. A similar study was already performed in adults and was found useful. The investigators now extend the clinical application to children.

Detailed Description

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Extravasation is the unintentional injection or leakage of fluids into the perivascular or subcutaneous space resulting in potential tissue injury. This prospective controlled study, will assesse the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of intravenous (IV) catheters in ventilated children. Diluted sodium bicarbonate will be created using undiluted standard 8.4% (1 meq/mL) sodium bicarbonate mixed in a 1:3 ratio with sterile water to achieve a final diluted concentration of 2.1% (0.25 mEq/mL). In 20 ASA I-II mechanically ventilated children age 2-8 years, the effects of 1 ml/kg of diluted 2.1% sodium bicarbonate or 0.9% normal saline,injected in a randomized order, will be analyzed. All children will have venous blood samples taken prior to injection and 10 minutes after injection for analysis of venous blood pH and electrolytes.

Conditions

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Verifying the Correct Position of Intravenous Catheters

Keywords

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infiltration extravasation end-tidal carbon dioxide sodium bicarbonate

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

Diluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2

Group Type EXPERIMENTAL

intravenous sodium bicarbonate

Intervention Type DEVICE

Dilted sodium bicarbonate 2.1%

control

equal volume of normal saline will be randomely injected

Group Type PLACEBO_COMPARATOR

intravenous sodium bicarbonate

Intervention Type DEVICE

Dilted sodium bicarbonate 2.1%

Interventions

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intravenous sodium bicarbonate

Dilted sodium bicarbonate 2.1%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA I,II
* age 2-8 years

Exclusion Criteria

* ASA III or higher
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv University

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ilan Keidan

director of pediatric anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-11-8207-IK-CTIL

Identifier Type: -

Identifier Source: org_study_id