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Clinical Trial 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


Clinical Trial 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 ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Detection of the Correct Position of Intravenous Line

NCT number NCT01748097
Study type Interventional
Source Sheba Medical Center
Contact ilan keidan, MD
Phone 97235302754
Email ilan.keidan@sheba.health.gov.il
Status Recruiting
Phase Phase 2/Phase 3
Start date December 2012
Completion date December 2013