Verifying the Correct Position of Intravenous CathetersPhase 1/2NCT01409083
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Children
A Phase 1/2 study testing intravenous sodium bicarbonate in people with Verifying the Correct Position of Intravenous Catheters, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Verifying the Correct Position of Intravenous Catheters
- What is being tested?
- intravenous sodium bicarbonate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I,II
- age 2-8 years
Who cannot join
- ASA III or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children
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.
Read the detailed description
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.
- Being tested
- intravenous sodium bicarbonate
- Keywords
- infiltration, extravasation, end-tidal carbon dioxide, sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous sodium bicarbonateDevice
Dilted sodium bicarbonate 2.1%
| Study group | Role | What they receive |
|---|---|---|
| intravenous bicarbonate | Experimental | Diluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2 Receives: Device: intravenous sodium bicarbonate |
| control | Placebo comparator | equal volume of normal saline will be randomely injected Receives: Device: intravenous sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in exhaled carbon dioxide
Measured: 0.5-10.00 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verifying the Correct Position of Intravenous CathetersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Ilan Keidan, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409083
- Sponsor's protocol ID
- SHEBA-11-8207-IK-CTIL
- Status last verified
- Dec 2012
- First submitted
- 2 Aug 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Intravenous Bicarbonate as a Tool to Verify the Intravascular Position of an IV Catheter in Children
- ClinicalTrials.gov ID
- NCT01409083
- Acronym / sponsor ID
- SHEBA-11-8207-IK-CTIL
- Keywords
- infiltration, extravasation, end-tidal carbon dioxide, sodium bicarbonate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous bicarbonate | Experimental | Device: intravenous sodium bicarbonateDiluted sodium bicarbonate will be injected to s new IV catheter expecting a rise in end-tidal CO2 |
| control | Placebo comparator | Device: intravenous sodium bicarbonateequal volume of normal saline will be randomely injected |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I,II
- age 2-8 years
Key exclusion criteria (1 listed)
- ASA III or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous sodium bicarbonateDilted sodium bicarbonate 2.1% | Device | control, intravenous bicarbonate |
Primary outcome
increase in exhaled carbon dioxide
Time frame: 0.5-10.00 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intravenous sodium bicarbonate in people with Verifying the Correct Position of Intravenous Catheters, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in exhaled carbon dioxide (time frame: 0.5-10.00 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.