Shoulder SurgeryNCT02284763
Modeling the Effect of EtCO2 on Cerebral Oxygenation
A study testing EtCO2 in people with Shoulder Surgery, run by Severance Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to investigate the relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- EtCO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jan 2015
- 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
- Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia
Who cannot join
- Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia
The aim of this study was to investigate the relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.
Read the detailed description
Even though mild hypercapnia in the beach chair position (BCP) under general anesthesia was effective in reducing cerebral desaturation, there is no comprehensive data with regard to the dose-effect relationship of EtCO2 on rSO2 in the BCP under general anesthesia. Pharmacodynamic modeling can be useful in describing this relationship in which concurrent mean arterial pressure changes and disease state can be considered as covariates. Therefore, we investigated the relationship between the EtCO2 and rSO2 and identified the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.
- Conditions
- Shoulder Surgery
- Being tested
- EtCO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtCO2Other
Initial data collection during BCP was performed following three conditions were satisfied: after start of surgery; at least 15 min after BCP (for stabilization of MAP); after ventilation frequency was adjusted to produce EtCO2 of 27-29 mmHg with tidal volume of 8 ml/kg. Data was collected every 3 min after decreasing ventilation frequency by 1-2 breaths/min to increase EtCO2 until 42-45 mmHg. Once the value of EtCO2 42-45 mmHg was reached, ventilator frequency was increased in the same way to decrease EtCO2 until 27-29 mmHg. Fraction of inspired oxygen of 50% was maintained and end-tidal desflurane concentration was adjusted to achieve bispectral index values of 40-55 during data collection.
| Study group | Role | What they receive |
|---|---|---|
| Change of EtCO2 | Experimental | Changes of rSO2 after adjustment of EtCO2 between 27-45 mmHg Receives: Other: EtCO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The parameters of indirect response model
fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2
Measured: 60 min
The factors that influence the model parameters
mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
- Investigators
- Dong Woo Han, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284763
- Sponsor's protocol ID
- 4-2014-0688
- Status last verified
- Feb 2015
- First submitted
- 20 Oct 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia
- ClinicalTrials.gov ID
- NCT02284763
- Acronym / sponsor ID
- 4-2014-0688
- Conditions
- Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Nov 2014 (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 relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.
Detailed description
Even though mild hypercapnia in the beach chair position (BCP) under general anesthesia was effective in reducing cerebral desaturation, there is no comprehensive data with regard to the dose-effect relationship of EtCO2 on rSO2 in the BCP under general anesthesia. Pharmacodynamic modeling can be useful in describing this relationship in which concurrent mean arterial pressure changes and disease state can be considered as covariates. Therefore, we investigated the relationship between the EtCO2 and rSO2 and identified the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Change of EtCO2 | Experimental | Other: EtCO2Changes of rSO2 after adjustment of EtCO2 between 27-45 mmHg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia
Key exclusion criteria (1 listed)
- Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V
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 |
|---|---|---|
| EtCO2Initial data collection during BCP was performed following three conditions were satisfied: after start of surgery; at least 15 min after BCP (for stabilization of MAP); after ventilation frequency was adjusted to produce EtCO2 of 27-29 mmHg with tidal volume of 8 ml/kg. Data was collected every 3 min after decreasing ventilation frequency by 1-2 breaths/min to increase EtCO2 until 42-45 mmHg. Once the value of EtCO2 42-45 mmHg was reached, ventilator frequency was increased in the same way to decrease EtCO2 until 27-29 mmHg. Fraction of inspired oxygen of 50% was maintained and end-tidal desflurane concentration was adjusted to achieve bispectral index values of 40-55 during data collection. | Other | Change of EtCO2 |
Primary outcome
The parameters of indirect response model
Time frame: 60 min
fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2
The factors that influence the model parameters
Time frame: 60 min
mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight
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 12 Feb 2015.
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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.
Dong Woo Han, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EtCO2 in people with Shoulder Surgery, run by Severance 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 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 12 Feb 2015. 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?
The parameters of indirect response model (time frame: 60 min). The study lists 2 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 12 Feb 2015.