Pulmonary Atelectasis, PostoperativeNCT04085146
Individual Optimal Positive End-expiratory Pressure During Robot-assisted Laparoscopic Radical Prostatectomy
A study testing Individualized optimal positive end-expiratory pressure and Conventional positive end-expiratory pressure in people with Pulmonary Atelectasis, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Pulmonary Atelectasis, Postoperative
- What is being tested?
- Individualized optimal positive end-expiratory pressure and Conventional positive end-expiratory pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2019to 7 Aug 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robot-assisted laparoscopic radical prostatectomy
- Patients receiving mechanical ventilation by Aisys Care Station anesthesia ventilator
- Patients who provided written informed consent to participate in this clinical trial
Who cannot join
- American Society of Anesthesiologists physical status classification class 3 or more
- Moderate or more obstructive or restrictive pulmonary disease
- Preoperative adult respiratory distress syndrome or previous history of adult respiratory distress syndrome
- history of heart failure, unstable angina, increased intracranial pressure
- history of pneumothorax or presence of bullae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP.
Read the detailed description
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP. We plan to determine the degree of immediate postoperative atelectasis by measuring the lung ultrasound score and compare the lung ultrasound score between groups.
- Conditions
- Pulmonary Atelectasis, Postoperative
- Being tested
- Individualized optimal positive end-expiratory pressure, Conventional positive end-expiratory pressure
- Keywords
- robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized optimal positive end-expiratory pressureProcedure or surgery
Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA).
Conventional positive end-expiratory pressureProcedure or surgery
A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Optimal PEEP | Experimental | Individualized optimal PEEP will be provided during the laparoscopic period of surgery. Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA). Receives: Procedure: Individualized optimal positive end-expiratory pressure |
| Conventional PEEP | Active comparator | A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery. Receives: Procedure: Conventional positive end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in lung ultrasound score
Difference in postoperative lung ultrasound score and baseline lung ultrasound score
Measured: 10 min after surgery
Secondary outcomes (9)
Baseline lung ultrasound score
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Measured: 10 min before the start of anesthesia induction
Composite of respiratory complication
summation of the following events: hypoxemia (pulse oximetry of 95% or less), laryngospasm, bronchospasm, pneumonia, pulmonary infiltration, aspiration pneumonia, pneumonia), pulmonary infiltration, aspiration pneumonia, development of acute respiratory distress syndrome, atelectasis, pleural effusion, pulmonary edema, pneumothorax.
Measured: during postoperative seven days.
Length of hospital stay
Length of total hospital stay
Measured: during the postoperative one month
Postoperative Lung ultrasound score
A scoring system with a sum of the B-line score and consolidation score by lung ultrasound examination
Measured: 10 min after the end of anesthesia
Length of intensive care unit stay
Length of total hospital stay
Measured: during the postoperative one month
Surgical wound infection
The rate of surgical wound infection
Measured: during the postoperative one month
Surgical wound dehiscence
The rate of surgical wound dehiscence
Measured: during the postoperative one month
Incidence of acute kidney injury
Incidence of postoperative acute kidney injury
Measured: during the postoperative one month
Incidence of surgical re-intervention
Incidence of surgical re-open
Measured: during the postoperative one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start19 Nov 2019
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Atelectasis, PostoperativeStudies 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
- Model description
- Randomized controlled superiority trial with two arms of intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085146
- Sponsor's protocol ID
- 1908-022-105
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04085146
- Acronym / sponsor ID
- 1908-022-105
- Conditions
- Pulmonary Atelectasis, Postoperative
- Keywords
- robot-assisted surgery, prostatectomy, laparoscopy, positive end-expiratory pressure, individualized, atelectasis, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 11 Sep 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.
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP.
Detailed description
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP. We plan to determine the degree of immediate postoperative atelectasis by measuring the lung ultrasound score and compare the lung ultrasound score between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled superiority trial with two arms of intervention.
| Arm | Type | Receives |
|---|---|---|
| Optimal PEEP | Experimental | Procedure: Individualized optimal positive end-expiratory pressureIndividualized optimal PEEP will be provided during the laparoscopic period of surgery. Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA). |
| Conventional PEEP | Active comparator | Procedure: Conventional positive end-expiratory pressureA same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing robot-assisted laparoscopic radical prostatectomy
- Patients receiving mechanical ventilation by Aisys Care Station anesthesia ventilator
- Patients who provided written informed consent to participate in this clinical trial
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists physical status classification class 3 or more
- Moderate or more obstructive or restrictive pulmonary disease
- Preoperative adult respiratory distress syndrome or previous history of adult respiratory distress syndrome
- history of heart failure, unstable angina, increased intracranial pressure
- history of pneumothorax or presence of bullae
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 |
|---|---|---|
| Individualized optimal positive end-expiratory pressureOptimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA). | Procedure or surgery | Optimal PEEP |
| Conventional positive end-expiratory pressureA same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery. | Procedure or surgery | Conventional PEEP |
Primary outcome
Difference in lung ultrasound score
Time frame: 10 min after surgery
Difference in postoperative lung ultrasound score and baseline lung ultrasound score
9 secondary outcomes
Baseline lung ultrasound score
Time frame: 10 min before the start of anesthesia induction
Composite of respiratory complication
Time frame: during postoperative seven days.
Length of hospital stay
Time frame: during the postoperative one month
Postoperative Lung ultrasound score
Time frame: 10 min after the end of anesthesia
Length of intensive care unit stay
Time frame: during the postoperative one month
Surgical wound infection
Time frame: during the postoperative one month
Surgical wound dehiscence
Time frame: during the postoperative one month
Incidence of acute kidney injury
Time frame: during the postoperative one month
Incidence of surgical re-intervention
Time frame: during the postoperative one month
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 21 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Atelectasis, Postoperative
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Enrolling by invitation
Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
Postoperative Pulmonary Complications (PPCs), Atelectasis
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
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 Individualized optimal positive end-expiratory pressure and Conventional positive end-expiratory pressure in people with Pulmonary Atelectasis, Postoperative, 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 5 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 21 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?
Difference in lung ultrasound score (time frame: 10 min 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 21 Oct 2021.