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Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers

NCT ID: NCT01458873

Last Updated: 2011-11-01

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

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

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Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Detailed Description

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Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.

The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.

Conditions

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Infiltration Extravasation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sodium bicarbonate 4.2%

sodium bicarbonate 4.2% 50 m"l

Group Type EXPERIMENTAL

sodium bicarbonate 4.2%

Intervention Type DRUG

diluted sodium bicarbonate 50 ml

sodium bicarbonate 2.1%

sodium bicarbonate 2.1% 1 50 m"l

Group Type EXPERIMENTAL

diluted sodium bicarbonate 2.1%

Intervention Type DRUG

50ml

normal saline

50 m"l normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

50ml

Interventions

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sodium bicarbonate 4.2%

diluted sodium bicarbonate 50 ml

Intervention Type DRUG

diluted sodium bicarbonate 2.1%

50ml

Intervention Type DRUG

normal saline

50ml

Intervention Type DRUG

Other Intervention Names

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sodium bicarbonate 2.1%

Eligibility Criteria

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Inclusion Criteria

* ASA I,II
* no cardiovascular or respiratory disease

Exclusion Criteria

* ASA \> II
* Cardiovascular disease
* Respiratory disease
* renal failure
* metabolic alkalosis
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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Dr. Ilan Keidan

Director, Pediatric Anesthesia, Sheba Medical center

Responsibility Role PRINCIPAL_INVESTIGATOR

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

[email protected]
972-3-5302754

Facility Contacts

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ilan keidan, MD

Role: primary

[email protected]
972-3-530-2754

References

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Keidan I, Ben-Menachem E, Barzilai A, Nur I, Berkenstadt H. Intravenous sodium bicarbonate verifies intravenous position of catheters in ventilated patients. Anesth Analg. 2011 Aug;113(2):279-81. doi: 10.1213/ANE.0b013e3182222ed0. Epub 2011 Jun 3.

Reference Type BACKGROUND
PMID: 21642603 (View on PubMed)

Keidan I, Sidi A, Ben-Menachem E, Derazne E, Berkenstadt H. A simple diagnostic test to confirm correct intravascular placement of peripheral catheters in order to avoid extravasation. J Clin Anesth. 2015 Nov;27(7):585-8. doi: 10.1016/j.jclinane.2015.07.004. Epub 2015 Aug 15.

Reference Type DERIVED
PMID: 26286133 (View on PubMed)

Other Identifiers

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SHEBA-11-8716-IK-CTIL

Identifier Type: -

Identifier Source: org_study_id