Mechanical Ventilation ComplicationNCT02191371
Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation
A study testing propofol and desflurane in people with Mechanical Ventilation Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- propofol and desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Dec 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing thoracic surgery including one-lung ventilation
Who cannot join
- refuse to enroll
- BMI over 30 kg/m(2)
- severe obstructive or restrictive lung disease
- preoperative supplemental oxygen, intubated, or mechanical ventilatory support
- preoperative arterial partial pressure of oxygen < 60 mmHg
- pregnancy
Show all 9Show fewer
- history of coronary artery disease
- preoperative continuous infusion of vasopressor or inotropes
- cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
Trial locations and contacts
1 site in 1 country.
About this study
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate during one-lung ventilation in the perspective of oxygenation and microcirculation. The investigators hypothesized that intravenous and inhalational anesthetics may affect oxygenation and microcirculation differently during one-lung ventilation.
Read the detailed description
Patients undergoing thoracic surgery including one-lung ventilation will be randomized to receive intravenous (propofol) or inhalational (desflurane) anesthetic.
Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare arterial partial pressure of oxygen and recovery slope during one-lung ventilation between propofol and desflurane group.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- propofol, desflurane
- Keywords
- oxygenation, microcirculation, one-lung ventilation, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
desfluraneDrug
Also called desflurane (Suprane(R), Baxter Healthcare)
Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4~5 mcg/ml, during general anesthesia Receives: Drug: propofol |
| desflurane | Experimental | Desflurane is used as a maintenance anesthetic to patients in the desflurane group.
Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6~8 vol% during general anesthesia Receives: Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial partial pressure of oxygen
Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
Measured: 30 min after one-lung ventilation
Secondary outcomes (1)
recovery slope
Secondary outcome is recovery slope measured by vascular occlusion test 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
Measured: 30 min after one-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunseok Jeon, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191371
- Sponsor's protocol ID
- PaO2 & StO2 in OLV
- Status last verified
- Aug 2014
- First submitted
- 7 Jul 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.
PubMed 28100177
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT02191371
- Acronym / sponsor ID
- PaO2 & StO2 in OLV
- Conditions
- Mechanical Ventilation Complication
- Keywords
- oxygenation, microcirculation, one-lung ventilation, thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jul 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.
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational anesthetics can be used during one-lung ventilation. However, there is still a controversy which anesthetic would be more appropriate during one-lung ventilation in the perspective of oxygenation and microcirculation. The investigators hypothesized that intravenous and inhalational anesthetics may affect oxygenation and microcirculation differently during one-lung ventilation.
Detailed description
Patients undergoing thoracic surgery including one-lung ventilation will be randomized to receive intravenous (propofol) or inhalational (desflurane) anesthetic.
Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare arterial partial pressure of oxygen and recovery slope during one-lung ventilation between propofol and desflurane group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: propofolPropofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4~5 mcg/ml, during general anesthesia |
| desflurane | Experimental | Drug: desfluraneDesflurane is used as a maintenance anesthetic to patients in the desflurane group. Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6~8 vol% during general anesthesia |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing thoracic surgery including one-lung ventilation
Key exclusion criteria (9 listed)
- refuse to enroll
- BMI over 30 kg/m(2)
- severe obstructive or restrictive lung disease
- preoperative supplemental oxygen, intubated, or mechanical ventilatory support
- preoperative arterial partial pressure of oxygen < 60 mmHg
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 |
|---|---|---|
| propofolAlso: propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic. | Drug | propofol |
| desfluraneAlso: desflurane (Suprane(R), Baxter Healthcare)Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic. | Drug | desflurane |
Primary outcome
arterial partial pressure of oxygen
Time frame: 30 min after one-lung ventilation
Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
1 secondary outcome
recovery slope
Time frame: 30 min after one-lung ventilation
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 13 Oct 2016.
- Derived from this study: PubMed 28100177Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation Complication
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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.
Yunseok Jeon, PhD principal investigator
Seoul National University 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 propofol and desflurane in people with Mechanical Ventilation Complication, 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 9 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 13 Oct 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 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?
arterial partial pressure of oxygen (time frame: 30 min after one-lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191371, which also lists 1 linked publication.
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 13 Oct 2016.