Video-assisted Thoracic SurgeryNCT03856918
Optimal Level of PEEP in Protective One-lung Ventilation
A study testing PEEP 3 cm of water, PEEP 6 cm of water and PEEP 9 cm of water in people with Video-assisted Thoracic Surgery and Postoperative Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Video-assisted Thoracic Surgery, Postoperative Atelectasis, Positive End-expiratory Pressure
- What is being tested?
- PEEP 3 cm of water, PEEP 6 cm of water and PEEP 9 cm of water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2019to 28 Feb 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation
Who cannot join
- Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
- Chronic kidney disease
- Coronary artery disease
- Pulmonary hypertension
- Bilateral lung surgery
- Conversion to thoracotomy
- American Society of Anesthesiologists physical status IV or more
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation
Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.
- Conditions
- Video-assisted Thoracic Surgery, Postoperative Atelectasis, Positive End-expiratory Pressure
- Being tested
- PEEP 3 cm of water, PEEP 6 cm of water, PEEP 9 cm of water
- Keywords
- Protective ventilation, One-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP 3 cm of waterProcedure or surgery
PEEP of 3 cm of water will be applied during one-lung ventilation.
PEEP 6 cm of waterProcedure or surgery
PEEP of 6 cm of water will be applied during one-lung ventilation.
PEEP 9 cm of waterProcedure or surgery
PEEP of 9 cm of water will be applied during one-lung ventilation.
| Study group | Role | What they receive |
|---|---|---|
| PEEP 3 cm of water | Experimental | Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery. Receives: Procedure: PEEP 3 cm of water |
| PEEP 6 cm of water | Experimental | Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery. Receives: Procedure: PEEP 6 cm of water |
| PEEP 9 cm of water | Experimental | Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery. Receives: Procedure: PEEP 9 cm of water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.
Measured: Postoperative 1 hour
Secondary outcomes (7)
Intraoperative desaturation
Oxygen saturation by pulse oximetry <95% during one-lung ventilation
Measured: Average time of 60-90 minutes
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation
Measured: Average time of 60-90 minutes
Postoperative desaturation
Oxygen saturation by pulse oximetry <95%
Measured: Postoperative 24 hours
plasma Tumor Necrosis Factor-α
proinflammatory cytokine
Measured: 10 minutes after initiation of one-lung ventilation
plasma Interleukin-6
proinflammatory cytokine
Measured: 10 minutes after initiation of one-lung ventilation
plasma Interleukin-10
anti-inflammatory cytokine
Measured: 10 minutes after initiation of one-lung ventilation
Postoperative pulmonary complication
Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration
Measured: Postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start28 May 2019
- Primary completion11 Feb 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracic SurgeryStudies 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, Outcomes assessor
- Enrolment
- 142 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
- Investigators
- Jae-Hyon Bahk, MD,PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856918
- Sponsor's protocol ID
- H-1901-086-1004
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2019
- Last updated
- 18 Apr 2022
- 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 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation
- ClinicalTrials.gov ID
- NCT03856918
- Acronym / sponsor ID
- H-1901-086-1004
- Conditions
- Video-assisted Thoracic Surgery, Postoperative Atelectasis, Positive End-expiratory Pressure
- Keywords
- Protective ventilation, One-lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 27 Feb 2019 (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.
Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP 3 cm of water | Experimental | Procedure: PEEP 3 cm of waterPatients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery. |
| PEEP 6 cm of water | Experimental | Procedure: PEEP 6 cm of waterPatients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery. |
| PEEP 9 cm of water | Experimental | Procedure: PEEP 9 cm of waterPatients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation
Key exclusion criteria (8 listed)
- Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
- Chronic kidney disease
- Coronary artery disease
- Pulmonary hypertension
- Bilateral lung surgery
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 |
|---|---|---|
| PEEP 3 cm of waterPEEP of 3 cm of water will be applied during one-lung ventilation. | Procedure or surgery | PEEP 3 cm of water |
| PEEP 6 cm of waterPEEP of 6 cm of water will be applied during one-lung ventilation. | Procedure or surgery | PEEP 6 cm of water |
| PEEP 9 cm of waterPEEP of 9 cm of water will be applied during one-lung ventilation. | Procedure or surgery | PEEP 9 cm of water |
Primary outcome
Modified lung ultrasound score
Time frame: Postoperative 1 hour
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.
7 secondary outcomes
Intraoperative desaturation
Time frame: Average time of 60-90 minutes
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time frame: Average time of 60-90 minutes
Postoperative desaturation
Time frame: Postoperative 24 hours
plasma Tumor Necrosis Factor-α
Time frame: 10 minutes after initiation of one-lung ventilation
plasma Interleukin-6
Time frame: 10 minutes after initiation of one-lung ventilation
plasma Interleukin-10
Time frame: 10 minutes after initiation of one-lung ventilation
Postoperative pulmonary complication
Time frame: Postoperative 7 days
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 Apr 2022.
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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.
Jae-Hyon Bahk, MD,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 PEEP 3 cm of water, PEEP 6 cm of water and PEEP 9 cm of water in people with Video-assisted Thoracic Surgery and Postoperative Atelectasis, 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 8 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 Apr 2022. 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?
Modified lung ultrasound score (time frame: Postoperative 1 hour). 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 Apr 2022.