Atelectasis, Postoperative PulmonaryNCT04327193
Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
A study testing Titrated PEEP based on driving pressure and Conventional PEEP in people with Atelectasis, Postoperative Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary
- What is being tested?
- Titrated PEEP based on driving pressure and Conventional PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2020to 6 Oct 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position
Who cannot join
- American Society of Anesthesiologists physical status IV or more
- Severe cardiovascular disease
- Severe chronic obstructive pulmonary disease, emphysema
- History of pneumothorax, bullae
- History of lung resection surgery
- Conversion to laparotomy
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongnogu, 03080
About this study
Official title: The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial
The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.
- Conditions
- Atelectasis, Postoperative Pulmonary
- Being tested
- Titrated PEEP based on driving pressure, Conventional PEEP
- Keywords
- Driving pressure, Positive end-expiratory pressure, Lung ultrasound
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated PEEP based on driving pressureProcedure or surgery
Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.
Conventional PEEPProcedure or surgery
Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Driving pressure | Experimental | The selected PEEP which makes the driving pressure lowest is applied during the operation. Receives: Procedure: Titrated PEEP based on driving pressure |
| Conventional | Active comparator | Conventional PEEP (5cmH2O) is applied. Receives: Procedure: Conventional PEEP |
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 part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Measured: 30 minutes after PACU administration
Secondary outcomes (5)
Modified lung ultrasound score
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
Measured: Intraoperative (at the end of operation before emergence)
Incidence of intraoperative desaturation
Oxygen saturation by pulse oximetry< 95%
Measured: Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Measured: Intraoperative (30 minutes after designated PEEP applied)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Measured: 30 minutes after PACU administration
Postoperative pulmonary complications
Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia
Measured: After operation~ postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start4 May 2020
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis, Postoperative PulmonaryStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susie Yoon, Seoul National University Hospital
- Investigators
- Susie Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327193
- Sponsor's protocol ID
- SYoon_DP_RALP
- Status last verified
- Oct 2021
- First submitted
- 26 Mar 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04327193
- Acronym / sponsor ID
- SYoon_DP_RALP
- Conditions
- Atelectasis, Postoperative Pulmonary
- Keywords
- Driving pressure, Positive end-expiratory pressure, Lung ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 31 Mar 2020 (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 investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving pressure | Experimental | Procedure: Titrated PEEP based on driving pressureThe selected PEEP which makes the driving pressure lowest is applied during the operation. |
| Conventional | Active comparator | Procedure: Conventional PEEPConventional PEEP (5cmH2O) is applied. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists physical status IV or more
- Severe cardiovascular disease
- Severe chronic obstructive pulmonary disease, emphysema
- History of pneumothorax, bullae
- History of lung resection 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 |
|---|---|---|
| Titrated PEEP based on driving pressureAlveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation. | Procedure or surgery | Driving pressure |
| Conventional PEEPAlveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation. | Procedure or surgery | Conventional |
Primary outcome
Modified lung ultrasound score
Time frame: 30 minutes after PACU administration
The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.
5 secondary outcomes
Modified lung ultrasound score
Time frame: Intraoperative (at the end of operation before emergence)
Incidence of intraoperative desaturation
Time frame: Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time frame: Intraoperative (30 minutes after designated PEEP applied)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time frame: 30 minutes after PACU administration
Postoperative pulmonary complications
Time frame: After operation~ postoperative day 3
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 15 Oct 2021.
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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.
Susie Yoon, MD 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 Titrated PEEP based on driving pressure and Conventional PEEP in people with Atelectasis, Postoperative Pulmonary, 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 7 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 15 Oct 2021. 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: 30 minutes after PACU administration). 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 15 Oct 2021.