Central Venous Oxygen SaturationNCT04017182
Correlation Between External Jugular Venous and Superior Vena Cava Central Venous Blood Oxygen Saturation in Patient Under General Anesthesia
An observational study of Central Venous Oxygen Saturation, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
After installation of central venous catheter in patients under general anesthesia, paired sample of superior vena cava central venous blood and right external jugular venous blood will be collected and send to central laboratory for venous blood gas analysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Venous Oxygen Saturation
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2021to 1 Dec 2021
- 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: Adult surgical patients undergoing surgery under general anesthesia in institutional operating theaters with superior vena cava central venous catheter installation anticipated.
Who may be able to join
- Written consent obtained from patient or next of kin a day before operation date
- Patient age between 18-65 years old undergoing syrgery under general anesthesia
- Superior vena cava central venous catheter anticipated for CVP mesurement, innotropic or vasopressor administration,pulmonary artery catheter insertion route
- Anticipated right external jugular venous sampling time less than 5 minutes
- The site of blood sample collection easily access during operation
Who cannot join
- No jugular central venous catheter installation or other route selected
- Duration of paired sample collection more than 10 minutes
- Can not collected blood sample from right external jugular vein within 3 attemps
- The site of blood sample collection difficulty access during operation
- Pateint or next of kin refuse to participate
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Ramathibodi Hospital
Bangkok, Bangkok, 10400
About this study
After installation of central venous catheter in patients under general anesthesia, paired sample of superior vena cava central venous blood and right external jugular venous blood will be collected and send to central laboratory for venous blood gas analysis. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined as primary outcome.
Read the detailed description
All patients age between 18-65 year old who undergoing surgery under general anesthesia and superior vena cava central venous catheter installation anticipated are eligible. The tips of superior vena cava central venous catheter was confirmed by Chest x-ray. Next 1 hour after skin incision, 1 ml of venous blood sample is taken from superior vena cava central venous catheter of right external jugular vein then send to central laboratory for venous blood gas analysis. The demographic data will be recorded. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined the primary outcome and partial pressure of carbon dioxide will be determined as a secondary outcome.
- Conditions
- Central Venous Oxygen Saturation
- Keywords
- central venous oxygen saturation, external jugular venous oxygen saturation, central venous catheter, external jugular vein, internal jugular vein, superior vena cava oxygen saturation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of venous oxygen saturation
Correlation of venous oxygen saturation between external jugular vein and superior vena cava
Measured: 1 hour
Secondary outcomes (2)
Correlation of venous partial pressure of carbon dioxide
Correlation of venous partial pressure of carbon dioxide between external jugular vein and superior vena cava
Measured: 1 hour
Relationship between superior vena cava central venous and external jugular venous oxygen saturation
Linear regression to determine prediction equation between superior vena cava oxygen saturation and external jugular vein oxygen saturation
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Apr 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanist Pravitharangul, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017182
- Sponsor's protocol ID
- 04072019
- Status last verified
- Mar 2021
- First submitted
- 4 Jul 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between External Jugular Venous and Superior Vena Cava Central Venous Blood Oxygen Saturation in Patient Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04017182
- Acronym / sponsor ID
- 04072019
- Conditions
- Central Venous Oxygen Saturation
- Keywords
- central venous oxygen saturation, external jugular venous oxygen saturation, central venous catheter, external jugular vein, internal jugular vein, superior vena cava oxygen saturation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 12 Jul 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.
After installation of central venous catheter in patients under general anesthesia, paired sample of superior vena cava central venous blood and right external jugular venous blood will be collected and send to central laboratory for venous blood gas analysis. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined as primary outcome.
Detailed description
All patients age between 18-65 year old who undergoing surgery under general anesthesia and superior vena cava central venous catheter installation anticipated are eligible. The tips of superior vena cava central venous catheter was confirmed by Chest x-ray. Next 1 hour after skin incision, 1 ml of venous blood sample is taken from superior vena cava central venous catheter of right external jugular vein then send to central laboratory for venous blood gas analysis. The demographic data will be recorded. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined the primary outcome and partial pressure of carbon dioxide will be determined as a secondary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult surgical patients undergoing surgery under general anesthesia in institutional operating theaters with superior vena cava central venous catheter installation anticipated.
Key inclusion criteria (5 listed)
- Written consent obtained from patient or next of kin a day before operation date
- Patient age between 18-65 years old undergoing syrgery under general anesthesia
- Superior vena cava central venous catheter anticipated for CVP mesurement, innotropic or vasopressor administration,pulmonary artery catheter insertion route
- Anticipated right external jugular venous sampling time less than 5 minutes
- The site of blood sample collection easily access during operation
Key exclusion criteria (5 listed)
- No jugular central venous catheter installation or other route selected
- Duration of paired sample collection more than 10 minutes
- Can not collected blood sample from right external jugular vein within 3 attemps
- The site of blood sample collection difficulty access during operation
- Pateint or next of kin refuse to participate
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
Correlation of venous oxygen saturation
Time frame: 1 hour
Correlation of venous oxygen saturation between external jugular vein and superior vena cava
2 secondary outcomes
Correlation of venous partial pressure of carbon dioxide
Time frame: 1 hour
Relationship between superior vena cava central venous and external jugular venous oxygen saturation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Central Venous Oxygen Saturation, run by Ramathibodi Hospital at 1 site in Thailand.
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 5 inclusion and 5 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 9 Mar 2021. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanist Pravitharangul, MD (66866633694, thnst_yu@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of venous oxygen saturation (time frame: 1 hour). 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 9 Mar 2021.