NeurosurgeryO2 FractionNCT01513213
Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient
An observational study of Neurosurgery, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurosurgery
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults age 18 to 65 scheduled for a surgical procedure that will last at least two hours and for whom arterial cannulation and at least two arterial blood gas analyses are planned during the surgery.
Who may be able to join
- Age 18 to 65.
- Scheduled for surgical procedure that will last at least 2 hours.
- Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity.
- At least two arterial blood gas analyses are planned during the surgery.
Who cannot join
- No arterial cannulation is necessary or planned for the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.
- Conditions
- Neurosurgery
- Keywords
- Arterial cannulation, Blood gas, Carbon dioxide, Arterial blood, Oxygen, Oxygen fractions
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient.
Compare the levels of carbon dioxide found in the patient's blood to the amounts of carbon dioxide and oxygen in the air that the patient inhales and exhales. If a relationship exists between the levels of carbon dioxide in the blood and the levels of carbon dioxide and oxygen inhaled and exhaled by the patient, anesthesiologists will be able to use this relationship to adjust ventilators during anesthesia without having to take blood from an artery.
Measured: At least 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur M Lam, MD, FRCPC, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513213
- Sponsor's protocol ID
- 5119S-11
- Acronym
- O2 Fraction
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2012
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient
- ClinicalTrials.gov ID
- NCT01513213
- Acronym / sponsor ID
- O2 Fraction / 5119S-11
- Conditions
- Neurosurgery
- Keywords
- Arterial cannulation, Blood gas, Carbon dioxide, Arterial blood, Oxygen, Oxygen fractions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Jan 2012 (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 evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 18 to 65 scheduled for a surgical procedure that will last at least two hours and for whom arterial cannulation and at least two arterial blood gas analyses are planned during the surgery.
Key inclusion criteria (4 listed)
- Age 18 to 65.
- Scheduled for surgical procedure that will last at least 2 hours.
- Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity.
- At least two arterial blood gas analyses are planned during the surgery.
Key exclusion criteria (1 listed)
- No arterial cannulation is necessary or planned for the procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient.
Time frame: At least 2 hours
Compare the levels of carbon dioxide found in the patient's blood to the amounts of carbon dioxide and oxygen in the air that the patient inhales and exhales. If a relationship exists between the levels of carbon dioxide in the blood and the levels of carbon dioxide and oxygen inhaled and exhaled by the patient, anesthesiologists will be able to use this relationship to adjust ventilators during anesthesia without having to take blood from an artery.
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 24 Jan 2017.
Related trials for Neurosurgery
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
RecruitingObservational study
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
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.
Arthur M Lam, MD, FRCPC principal investigator
Swedish Medical Center
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 Neurosurgery, run by Swedish Medical Center 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 4 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 24 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?
Correlate the level of carbon dioxide within arterial blood to inspired and expired oxygen gradient. (time frame: At least 2 hours). 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 24 Jan 2017.