Arterial Oxygenation During Protective One Lung VentilationPhase 2NCT01191606
Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation
A Phase 2 study testing the change of ventilatory mode in people with Arterial Oxygenation During Protective One Lung Ventilation, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Arterial Oxygenation During Protective One Lung Ventilation
- What is being tested?
- the change of ventilatory mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation
Who cannot join
- patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jin Young Hwang, MD, 82-31-787-7508, mistyblue15@naver.com
Jin Young Hwang, MD
About this study
Official title: Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation for Thoracic Surgery
The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.
Read the detailed description
One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.
During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.
- Being tested
- the change of ventilatory mode
- Keywords
- pressure controlled, volume controlled, arterial oxygenation, one lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the change of ventilatory modeProcedure or surgery
Also called VCV-PCV group
One lung ventilation initiated with volume controlled ventilation(OLV-VCV) with an inspired oxygen fraction (FIO2) of 1.0, a tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to pressure controlled ventilation and the inspiratory pressure was adjusted to obtain the tidal volume 6 mL/kg. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.
the change of ventilatory modeProcedure or surgery
Also called PCV-VCV group
One lung ventilation initiated with pressure controlled ventilation with an inspired oxygen fraction (FIO2) of 1.0, an inspiratory pressure provided the tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to VCV with a tidal volume 6 mL/kg based on PBW. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | the exchange of ventilatory mode from volume controlled ventilation to pressure controlled ventilation Receives: Procedure: the change of ventilatory mode |
| Group B | Active comparator | the exchange of ventilatory mode from pressure controlled ventilation to volume controlled ventilation Receives: Procedure: the change of ventilatory mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygenation differences
(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.
Measured: four time points during operation
Secondary outcomes (3)
peak inspiratory pressure (Ppeak)
(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.
Measured: four time points during operation
mean inspiratory pressure (Pmean)
(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.
Measured: four time points during operation
plateau inspiratory pressure (Pplateau)
(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.
Measured: four time points during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Oxygenation During Protective One Lung VentilationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin Young Hwang, MD, Principal investigator, Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191606
- Sponsor's protocol ID
- B-1005-100-003
- Status last verified
- May 2010
- First submitted
- 5 Aug 2010
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation for Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01191606
- Acronym / sponsor ID
- B-1005-100-003
- Keywords
- pressure controlled, volume controlled, arterial oxygenation, one lung ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 Aug 2010 (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 is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.
Detailed description
One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.
During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: the change of ventilatory modethe exchange of ventilatory mode from volume controlled ventilation to pressure controlled ventilation |
| Group B | Active comparator | Procedure: the change of ventilatory modethe exchange of ventilatory mode from pressure controlled ventilation to volume controlled ventilation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation
Key exclusion criteria (1 listed)
- patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure
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 |
|---|---|---|
| the change of ventilatory modeAlso: VCV-PCV groupOne lung ventilation initiated with volume controlled ventilation(OLV-VCV) with an inspired oxygen fraction (FIO2) of 1.0, a tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to pressure controlled ventilation and the inspiratory pressure was adjusted to obtain the tidal volume 6 mL/kg. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode. | Procedure or surgery | Group A |
| the change of ventilatory modeAlso: PCV-VCV groupOne lung ventilation initiated with pressure controlled ventilation with an inspired oxygen fraction (FIO2) of 1.0, an inspiratory pressure provided the tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to VCV with a tidal volume 6 mL/kg based on PBW. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode. | Procedure or surgery | Group B |
Primary outcome
arterial oxygenation differences
Time frame: four time points during operation
(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.
3 secondary outcomes
peak inspiratory pressure (Ppeak)
Time frame: four time points during operation
mean inspiratory pressure (Pmean)
Time frame: four time points during operation
plateau inspiratory pressure (Pplateau)
Time frame: four time points during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
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.
Jin Young Hwang, MD principal investigator
Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing the change of ventilatory mode in people with Arterial Oxygenation During Protective One Lung Ventilation, run by Seoul National University Bundang 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: status not confirmed, as of the sponsor's last update on 31 Aug 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jin Young Hwang, MD (82-31-787-7508, mistyblue15@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial oxygenation differences (time frame: four time points during operation). 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 31 Aug 2010.