Cerebral Oxygen SaturationNCT02687334
Changes of Cerebral Oxygenation During Anesthesia Induction
An observational study of Cerebral Oxygen Saturation, run by China Medical University, China at 1 site in China.
Trial summary
The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cerebral Oxygen Saturation
- What is being tested?
- 100% Oxygen
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to May 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients scheduled for elective radical operations for mastocarcinomaat in the First Hospital of China Medical University will be recruited for the study
Who may be able to join
- Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma.
Who cannot join
- Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.
Read the detailed description
The aim of this study was to investigate the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of anesthesia induction.
- Conditions
- Cerebral Oxygen Saturation
- Being tested
- 100% Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% OxygenDrug
We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen
| Study group | Role | What they receive |
|---|---|---|
| Standard general anesthesia induction | Patients scheduled for elective surgery at the First Hospital of China Medical University will be recruited for the study beginning in February 2016.We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia Receives: Drug: 100% Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of cerebral oxygen saturation
the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood
Measured: Baseline and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Oxygen SaturationStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Wen-fei Tan, M.D.,PhD., Principal investigator, the First Hoapital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687334
- Sponsor's protocol ID
- 2015110301
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Cerebral Oxygenation During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT02687334
- Acronym / sponsor ID
- 2015110301
- Conditions
- Cerebral Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Feb 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 aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.
Detailed description
The aim of this study was to investigate the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood and to identify the covariates between rSO2 and PaCO2 and PaO2 during the period of anesthesia induction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard general anesthesia induction | – | Drug: 100% OxygenPatients scheduled for elective surgery at the First Hospital of China Medical University will be recruited for the study beginning in February 2016.We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients scheduled for elective radical operations for mastocarcinomaat in the First Hospital of China Medical University will be recruited for the study
Key inclusion criteria (1 listed)
- Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma.
Key exclusion criteria (1 listed)
- Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.
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 |
|---|---|---|
| 100% OxygenWe will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen | Drug | Standard general anesthesia induction |
Primary outcome
changes of cerebral oxygen saturation
Time frame: Baseline and 30 minutes
the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood
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 10 May 2016.
- Individual participant dataSharing planned: Yes
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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.
Wen-fei Tan, M.D.,PhD. principal investigator
the First Hoapital of China Medical University
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 Cerebral Oxygen Saturation, run by China Medical University, China at 1 site in China.
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 10 May 2016. 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 China. 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?
changes of cerebral oxygen saturation (time frame: Baseline and 30 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 10 May 2016.