One-Lung VentilationNCT02851238
Driving Pressure and Postoperative Pulmonary Complications
A study testing Driving Pressure Limited Ventilation in people with One-Lung Ventilation and Postoperative Respiratory Complications, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- One-Lung Ventilation, Postoperative Respiratory Complications, Driving Pressure
- What is being tested?
- Driving Pressure Limited Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2016to 1 Sep 2017
- 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
- Adults greater than or equal to 19 years
- Patient who undergoes one-lung ventilation for thoracic surgery
Who cannot join
- The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
- Patient who is contraindicated with application of positive end expiratory pressure
- Patient who rejects being enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study
This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.
- Being tested
- Driving Pressure Limited Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Pressure Limited VentilationOther
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Protective Ventilation | No intervention | The control arm receives existing conventional protective ventilation with tidal volume of 6mL/kg of ideal body weight and positive end expiratory ventilation of 5cmH2O during one-lung ventilation |
| Driving Pressure Limited Ventilation | Experimental | The intervention arm receives driving pressure limited ventilation during one-lung ventilation Receives: Other: Driving Pressure Limited Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative pulmonary complications
Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.
Measured: within the first 3 days after surgery
Secondary outcomes (2)
Partial pressure of oxygen in arterial blood
Measured: during surgery
The ratio of partial pressure arterial oxygen and fraction of inspired oxygen
The ratio will be obtained from the first arterial blood gas analysis on the first postoperative day.
Measured: on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start12 Aug 2016
- Primary completion31 Aug 2017
- Study completion1 Sep 2017
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 Samsung Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Joo Ahn, Samsung Medical Center
- Investigators
- Hyun Joo Ahn, Ph.D., Principal investigator, Department of Anesthesiology and Pain Medicine, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851238
- Sponsor's protocol ID
- SMC 2016-05-107-003
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Pressure Limited Ventilation Decreases Postoperative Pulmonary Complications in One-Lung Ventilation: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02851238
- Acronym / sponsor ID
- SMC 2016-05-107-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 1 Aug 2016 (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.
This study aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protective Ventilation | No intervention | –The control arm receives existing conventional protective ventilation with tidal volume of 6mL/kg of ideal body weight and positive end expiratory ventilation of 5cmH2O during one-lung ventilation |
| Driving Pressure Limited Ventilation | Experimental | Other: Driving Pressure Limited VentilationThe intervention arm receives driving pressure limited ventilation during one-lung ventilation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults greater than or equal to 19 years
- Patient who undergoes one-lung ventilation for thoracic surgery
Key exclusion criteria (3 listed)
- The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
- Patient who is contraindicated with application of positive end expiratory pressure
- Patient who rejects being enrolled in the study
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 |
|---|---|---|
| Driving Pressure Limited VentilationPositive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation | Other | Driving Pressure Limited Ventilation |
Primary outcome
The incidence of postoperative pulmonary complications
Time frame: within the first 3 days after surgery
Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.
2 secondary outcomes
Partial pressure of oxygen in arterial blood
Time frame: during surgery
The ratio of partial pressure arterial oxygen and fraction of inspired oxygen
Time frame: on the first postoperative day
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 9 Oct 2018.
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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.
Hyun Joo Ahn, Ph.D. principal investigator
Department of Anesthesiology and Pain Medicine, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Pressure Limited Ventilation in people with One-Lung Ventilation and Postoperative Respiratory Complications, run by Samsung Medical Center 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 2 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 9 Oct 2018. 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 incidence of postoperative pulmonary complications (time frame: within the first 3 days after surgery). 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 9 Oct 2018.