One-lung VentilationNCT03234621
Protective Ventilation Strategy
A study testing ventilator setting during one-lung ventilation in people with One-lung Ventilation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- One-lung Ventilation
- What is being tested?
- ventilator setting during one-lung ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2017to 31 Jan 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective thoracic surgery
- ASA I, II, III
- scheduled > 2 hours of surgery
Who cannot join
- denied patients
- age under 18 years
- FEV1/FVC or FEV1<70% in preoperative pulmonary function test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications
The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications
- Conditions
- One-lung Ventilation
- Being tested
- ventilator setting during one-lung ventilation
- Keywords
- protective ventilation strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilator setting during one-lung ventilationOther
providing various tidal volumes according to the groups with constant PEEP
| Study group | Role | What they receive |
|---|---|---|
| conventional tidal group | Experimental | provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation Receives: Other: ventilator setting during one-lung ventilation |
| low tidal group | Experimental | provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation Receives: Other: ventilator setting during one-lung ventilation |
| high tidal group | Experimental | provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation Receives: Other: ventilator setting during one-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complications
PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration
Measured: immediately after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start12 Jul 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-lung VentilationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234621
- Sponsor's protocol ID
- JHBahk_PV
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT03234621
- Acronym / sponsor ID
- JHBahk_PV
- Conditions
- One-lung Ventilation
- Keywords
- protective ventilation strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 31 Jul 2017 (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.
The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional tidal group | Experimental | Other: ventilator setting during one-lung ventilationprovide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation |
| low tidal group | Experimental | Other: ventilator setting during one-lung ventilationprovide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation |
| high tidal group | Experimental | Other: ventilator setting during one-lung ventilationprovide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing elective thoracic surgery
- ASA I, II, III
- scheduled > 2 hours of surgery
Key exclusion criteria (3 listed)
- denied patients
- age under 18 years
- FEV1/FVC or FEV1<70% in preoperative pulmonary function test
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 |
|---|---|---|
| ventilator setting during one-lung ventilationproviding various tidal volumes according to the groups with constant PEEP | Other | conventional tidal group, high tidal group, low tidal group |
Primary outcome
postoperative pulmonary complications
Time frame: immediately after operation
PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration
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 16 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilator setting during one-lung ventilation in people with One-lung Ventilation, 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 3 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 16 Apr 2024. 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?
postoperative pulmonary complications (time frame: immediately after 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 16 Apr 2024.