Intravenous Bicarbonate To Verify The Correct Position of IV Catheters in Oncological Patients Oncological Patients Receiving Chemotherapy

Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01748097

Acronym

IVBICONCOL

Enrollment

100

Registered

2012-12-12

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection of the Correct Position of Intravenous Line

Keywords

infiltration, extravasation, sodium bicarbonate, capnography, end tidal carbon dioxide, chemotherapy

Brief summary

The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue

Detailed description

The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients. each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria). Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories: 1. IV in place ready to use for chemotherapy ( good blood return) 2. Doubtful position ( no blood return/ little blood return bu flushes well). 3. IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections

Interventions

DRUGsodium bicarbonate 4.2%

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* age 18-80 oncological disease requires intravenous chemotherapy

Exclusion criteria

* 1\. refusal to participate 2. lung disease acute or chronic sPo2 \< 92%, PaCO2 \> 50 3. renal failure Creatinine \> 2 mg% 4. metabolic alkalosis HCO3 \> 30 meq/L 5. medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid 6. obesity BMI \> 38 7. congestive heart failure EF \< 40 % or clinical signs of congestive heart failure

Design outcomes

Primary

Measure	Time frame	Description
change in exhaled end tidal co2	1-3 minutes	the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2

Countries

Israel

Contacts

Primary Contactilan keidan, MD

ilan.keidan@sheba.health.gov.il97235302754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026