General AnesthesiaPhase 1NCT01219322
Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Anesthetized Children
A Phase 1 study testing Sodium bicarbonate and normal saline in people with General Anesthesia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Sodium bicarbonate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers
Who cannot join
- respiratory disease
- active smoking
- cardiovascular disease
- renal disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, 52361
Ilan Keidan, MD, 972-3-530-2754, ilan.keidan@sheba.health.gov.il
About this study
Official title: Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter
Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.
Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.
- Conditions
- General Anesthesia
- Being tested
- Sodium bicarbonate, normal saline
- Keywords
- general endotracheal anesthesia, ASA I or II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Also called 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.
single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc
normal salineDrug
intravenous normal saline volume equivalent to sodium bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| intravenous bicarbonate | Experimental | Intravenous bicarbonate(05meq/cc ) 50 cc will be injected. Receives: Drug: Sodium bicarbonate |
| Intravenous injection of 50 cc normal saline | Placebo comparator | Injection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in end-tidal carbon dioxide
intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes
Measured: 0.5-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219322
- Sponsor's protocol ID
- SHEBA-09-7458-IK-CTIL
- Status last verified
- Oct 2010
- First submitted
- 10 Oct 2010
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter
- ClinicalTrials.gov ID
- NCT01219322
- Acronym / sponsor ID
- SHEBA-09-7458-IK-CTIL
- Conditions
- General Anesthesia
- Keywords
- general endotracheal anesthesia, ASA I or II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 13 Oct 2010 (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.
Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.
Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.
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 | Drug: Sodium bicarbonateIntravenous bicarbonate(05meq/cc ) 50 cc will be injected. |
| Intravenous injection of 50 cc normal saline | Placebo comparator | Drug: normal salineInjection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers
Key exclusion criteria (4 listed)
- respiratory disease
- active smoking
- cardiovascular disease
- renal disease
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 |
|---|---|---|
| Sodium bicarbonateAlso: 8.4% w/v Sodium bicarbonate B Braun Melsungen, Germany.single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc | Drug | intravenous bicarbonate |
| normal salineintravenous normal saline volume equivalent to sodium bicarbonate | Drug | Intravenous injection of 50 cc normal saline |
Primary outcome
change in end-tidal carbon dioxide
Time frame: 0.5-2 minutes
intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium bicarbonate and normal saline in people with General Anesthesia, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2010. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan keidan, MD (972-3-530-2754, ilan.keidan@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in end-tidal carbon dioxide (time frame: 0.5-2 minutes). 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 28 Oct 2010.