AnemiaNCT04144205
Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation
A study testing Change of the fraction of inspired oxygen in people with Anemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Change of the fraction of inspired oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2019to 11 Feb 2020
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.
Who cannot join
- Emergent surgery
- Symptomatic carotid artery stenosis or carotid artery stenosis of ≥50%
- Preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation and Regional Cerebral Oxygen Saturation During Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery: a Pilot Study
Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. However, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. Therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.
- Conditions
- Anemia
- Being tested
- Change of the fraction of inspired oxygen
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of the fraction of inspired oxygenOther
After the stabilization of cardiopulmonary bypass, in the first half of patients, fraction of inspired oxygen would be set at 0.5 and maintained for 5 minutes (T0), then it would be changed to 1.0 and maintained for 5 minutes (T1). Again, fraction of inspired oxygen would be resumed to be 0.5 and maintained for 5 minutes (T2).
In the other half of patients, the direction of change in fraction of inspired oxygen will be reversed as follows. It will be set at 1.0 and maintained for 5 minutes (T0), then changed to 0.5 and maintained for 5 minutes (T1), and finally to 1.0 and maintained for 5 minutes (T2).
| Study group | Role | What they receive |
|---|---|---|
| Fraction of inspired oxygen setting change | Experimental | Not described Receives: Other: Change of the fraction of inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mixed venous oxygen saturation
Change of mixed venous oxygen saturation according to the fraction of inspired oxygen
Measured: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Secondary outcomes (1)
Cerebral regional oxygen saturation
Change of cerebral regional oxygen saturation according to the fraction of inspired oxygen
Measured: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start4 Nov 2019
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144205
- Sponsor's protocol ID
- PaO2 and SvO2
- Status last verified
- Feb 2020
- First submitted
- 28 Oct 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Arterial Oxygen Partial Pressure on Mixed Venous Oxygen Saturation and Regional Cerebral Oxygen Saturation During Cardiopulmonary Bypass in Patients Undergoing Cardiac Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT04144205
- Acronym / sponsor ID
- PaO2 and SvO2
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- 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.
Mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. Factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. Among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. However, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. Therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fraction of inspired oxygen setting change | Experimental | Other: Change of the fraction of inspired oxygen |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass.
Key exclusion criteria (3 listed)
- Emergent surgery
- Symptomatic carotid artery stenosis or carotid artery stenosis of ≥50%
- Preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.
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 |
|---|---|---|
| Change of the fraction of inspired oxygenAfter the stabilization of cardiopulmonary bypass, in the first half of patients, fraction of inspired oxygen would be set at 0.5 and maintained for 5 minutes (T0), then it would be changed to 1.0 and maintained for 5 minutes (T1). Again, fraction of inspired oxygen would be resumed to be 0.5 and maintained for 5 minutes (T2). In the other half of patients, the direction of change in fraction of inspired oxygen will be reversed as follows. It will be set at 1.0 and maintained for 5 minutes (T0), then changed to 0.5 and maintained for 5 minutes (T1), and finally to 1.0 and maintained for 5 minutes (T2). | Other | Fraction of inspired oxygen setting change |
Primary outcome
Mixed venous oxygen saturation
Time frame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
Change of mixed venous oxygen saturation according to the fraction of inspired oxygen
1 secondary outcome
Cerebral regional oxygen saturation
Time frame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.
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 Feb 2020.
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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.
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 study testing Change of the fraction of inspired oxygen in people with Anemia, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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 Feb 2020. 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 South Korea. 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?
Mixed venous oxygen saturation (time frame: From the beginning and the stabilization of cardiopulmonary bypass to 15 minutes thereafter.). 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 Feb 2020.