Obese Patients, One Lung VentilationNCT02185378
Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
A study testing I:E ratio 1:2 and I:E ratio 1:1 in people with Obese Patients, One Lung Ventilation, run by Yonsei University at 1 site in South Korea.
Trial summary
One-lung ventilation, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Obese Patients, One Lung Ventilation
- What is being tested?
- I:E ratio 1:2 and I:E ratio 1:1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 40 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- Obesity (BMI >25 kg/ m2 )
- thoracic surgical procedure
Who cannot join
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- reduced pulmonary diffusion capacity < 80%
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
One-lung ventilation, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the restrictive ventilatory effects of obesity, these patients often show a decreased functional residual capacity and decreased expiratory reserve volume, leading to an overall decreased tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt shunting. There are few studies on the one lung ventilation in obese patients about this prolonged inspiratory time ventilatory method. We plan to investigate the effect of this ventilation method in obese patients during one lung ventilation.
- Conditions
- Obese Patients, One Lung Ventilation
- Being tested
- I:E ratio 1:2, I:E ratio 1:1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I:E ratio 1:2Procedure or surgery
We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.
I:E ratio 1:1Procedure or surgery
The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
| Study group | Role | What they receive |
|---|---|---|
| I:E ratio 1:2 | Active comparator | We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients. Receives: Procedure: I:E ratio 1:2 |
| I:E ratio 1:1 | Active comparator | The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients. Receives: Procedure: I:E ratio 1:1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2), CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
Measured: T1 (10min before one lung ventibation) T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started) T4 (10min after two lung ventilation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 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 Obese Patients, One Lung VentilationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, MD,PhD, Principal investigator, Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185378
- Sponsor's protocol ID
- 4-2014-0302
- Status last verified
- Mar 2019
- First submitted
- 3 Jul 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 1:1 Inspiratory to Expiratory Ratios on Oxygenation and Intrapulmonary Shunt Fraction During One Lung Ventilation in the Obese Patients
- ClinicalTrials.gov ID
- NCT02185378
- Acronym / sponsor ID
- 4-2014-0302
- Conditions
- Obese Patients, One Lung Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 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, even in patients with healthy weight, causes an impairment in gas-exchange and respiratory mechanics. We hypothesized that oxygenation during the one-lung ventilation in obese patients would be improved by applying inverse-ratio ventilation, reducing atelectasis in the dependent lung and resulting in reduced shunt. Because of the restrictive ventilatory effects of obesity, these patients often show a decreased functional residual capacity and decreased expiratory reserve volume, leading to an overall decreased tidal volume. These reduction leads to arterial hypoxemia, V-Q mismatch and Rt to Lt shunting. There are few studies on the one lung ventilation in obese patients about this prolonged inspiratory time ventilatory method. We plan to investigate the effect of this ventilation method in obese patients during one lung ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I:E ratio 1:2 | Active comparator | Procedure: I:E ratio 1:2We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients. |
| I:E ratio 1:1 | Active comparator | Procedure: I:E ratio 1:1The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 40 years of age.
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- Obesity (BMI >25 kg/ m2 )
- thoracic surgical procedure
Key exclusion criteria (3 listed)
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- reduced pulmonary diffusion capacity < 80%
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 |
|---|---|---|
| I:E ratio 1:2We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients. | Procedure or surgery | I:E ratio 1:2 |
| I:E ratio 1:1The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients. | Procedure or surgery | I:E ratio 1:1 |
Primary outcome
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter
Time frame: T1 (10min before one lung ventibation) T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started) T4 (10min after two lung ventilation)
shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2), CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
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 18 Mar 2019.
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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.
Young Jun Oh, MD,PhD principal investigator
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I:E ratio 1:2 and I:E ratio 1:1 in people with Obese Patients, One Lung Ventilation, run by Yonsei University 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 4 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 18 Mar 2019. 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?
Changes of the intrapulmonary shunt fraction and respiratory dynamic parameter (time frame: T1 (10min before one lung ventibation) T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started) T4 (10min after two lung ventilation)). 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 18 Mar 2019.