NCT01748097

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 10, 2012

Last Update Submit

December 30, 2012

Conditions

Detection of the Correct Position of Intravenous Line

Keywords

infiltrationextravasationsodium bicarbonatecapnographyend tidal carbon dioxidechemotherapy

Outcome Measures

Primary Outcomes (1)

  • change in exhaled end tidal co2

    the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2

    1-3 minutes

Study Arms (2)

IV bicarbonate 4.2% 20 cc

EXPERIMENTAL

injecting 20cc 4.2% to a newly administered IV line

Drug: sodium bicarbonate 4.2%

IV normal saline

PLACEBO COMPARATOR

injecting 20 cc normal saline to a newly administered IV line

Interventions

sodium bicarbonate 4.2%DRUG
IV bicarbonate 4.2% 20 cc

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80 oncological disease requires intravenous chemotherapy

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheba Medical Center Oncology

Tel Litwinsky, Israel, 52621, Israel

RECRUITING

Oncology Clinic

Tel Litwinsky, 52621, Israel

NOT YET RECRUITING

Central Study Contacts

ilan keidan, MD

CONTACT

97235302754ilan.keidan@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director pediatric anesthesia

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

IL(2)