Arterial AccessNCT02888431
Correlation of Arterial and Venous Lactate and Base Deficit Values
An observational study of Arterial Access and Peripheral Access, run by Joseph D. Tobias at 1 site in United States.
Trial summary
The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Access, Peripheral Access, Central Venous Catheter
- What is being tested?
- bedside point-of-care device
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.
Who may be able to join
- Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.
Who cannot join
- Patients who not require arterial access.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.
- Conditions
- Arterial Access, Peripheral Access, Central Venous Catheter
- Being tested
- bedside point-of-care device
- Keywords
- pH, base deficit, lactate values, venous blood samples, arterial blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside point-of-care deviceDevice
A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.
| Study group | Role | What they receive |
|---|---|---|
| Arterial blood sample | 0.5 mL blood sample from arterial line which is clinically indicated Receives: Device: bedside point-of-care device | |
| peripheral venous blood sample | 0.5 mL blood sample drawn simultaneously with arterial sample from clinically indicated peripheral line Receives: Device: bedside point-of-care device |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate blood value
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the lactate value will be assessed by using a bedside point-of-care device, called i-stat.
Measured: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
base deficit blood value
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the base deficit blood value will be assessed by using a bedside point-of-care device, called i-stat.
Measured: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
pH blood value
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then pH blood value will be assessed by using a bedside point-of-care device, called i-stat.
Measured: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial AccessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph D. Tobias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph Tobias, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888431
- Sponsor's protocol ID
- IRB15-00793
- Status last verified
- Jan 2017
- First submitted
- 17 Aug 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Arterial and Venous Lactate and Base Deficit Values
- ClinicalTrials.gov ID
- NCT02888431
- Acronym / sponsor ID
- IRB15-00793
- Conditions
- Arterial Access, Peripheral Access, Central Venous Catheter
- Keywords
- pH, base deficit, lactate values, venous blood samples, arterial blood samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Joseph D. TobiasUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Sep 2016 (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.
The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterial blood sample | – | Device: bedside point-of-care device0.5 mL blood sample from arterial line which is clinically indicated |
| peripheral venous blood sample | – | Device: bedside point-of-care device0.5 mL blood sample drawn simultaneously with arterial sample from clinically indicated peripheral line |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.
Key inclusion criteria (1 listed)
- Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.
Key exclusion criteria (1 listed)
- Patients who not require arterial access.
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 |
|---|---|---|
| bedside point-of-care deviceA bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH. | Device | Arterial blood sample, peripheral venous blood sample |
Primary outcome
lactate blood value
Time frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the lactate value will be assessed by using a bedside point-of-care device, called i-stat.
base deficit blood value
Time frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then the base deficit blood value will be assessed by using a bedside point-of-care device, called i-stat.
pH blood value
Time frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
blood will be drawn from peripheral venous line, arterial line, and/or central venous line then pH blood value will be assessed by using a bedside point-of-care device, called i-stat.
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 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Tobias principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Access and Peripheral Access, run by Joseph D. Tobias at 1 site in United States.
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 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 31 Jan 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
lactate blood value (time frame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)). The study lists 3 primary outcomes in all. 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 31 Jan 2017.