Pulmonary ComplicationsNCT02931409
Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response
A study testing Optimal PEEP and Standard PEEP in people with Pulmonary Complications and Inflammatory Response, run by Péterfy Sándor Hospital at 2 sites in Hungary.
Trial summary
The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complications, Inflammatory Response
- What is being tested?
- Optimal PEEP and Standard PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesHungary
- Study dates
- Oct 2016to 31 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bladder cancer undergoing radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute)
Who cannot join
- Age < 18 years
- ASA grade IV
- History of severe chronic obstructive pulmonary disease (COPD, GOLD grade III or IV)
- History of severe or uncontrolled bronchial asthma
- History of severe restrictive pulmonary disease
- Pulmonary metastases
Show all 12Show fewer
- History of any thoracic surgery
- Need for thoracic drainage before surgery
- Renal replacement therapy prior to surgery
- Congestive heart failure (NYHA grade III or IV)
- Extreme obesity (BMI > 35 Kg/m2)
- Lack of patient's consent
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Péterfy Sándor Hospital
Budapest, Pest County, 1076
University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6722
About this study
Official title: Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response. A Double-center, Prospective, Randomized Controlled Trial
The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. A total number of 40 patients undergoing open radical cystectomy and urinary diversion will be enrolled and randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will be performed in control group and an optimal PEEP value determined during a static pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery until the third postoperative day as well as postoperative pulmonary complications. Clinical condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.
Read the detailed description
Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis or even hyperdistension of the lungs can occur leading to adverse consequences either intraoperatively or postoperatively. Lung protective ventilation (LPV, PEEP = 6 cmH2O, TV = 6 mL/Kg IBW and regular recruitments) during the intraoperative period can reduce the risk of ventilator induced lung injury (VILI) and prevent the formation of pulmonary atelectasis.
In our investigator-initiated, double-center, single-blinded, prospective, randomized, controlled clinical trial a total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into two groups. Standard lung protective mechanical ventilation with the use of 6 cmH2O of PEEP and low tidal volumes (6mL/Kg IBW), a fraction of inspired oxygen (FiO2) of 0.5 and a respiratory rate to maintain an end tidal carbon dioxide (ETCO2) between 35-40 mmHg will be performed in control group, and a strategy of lung protective mechanical ventilation applying an optimal, individual PEEP determined by static pulmonary compliance (Cstat) directed PEEP titration procedure will be performed in study group.
During preoperative assessment, respiratory failure risk index (RFRI) will be recorded and informed consent will be obtained. Regarding to the protocol, a central vein catheter will be placed on the day before surgery, serum procalcitonin (PCT) level will be measured and a chest X-ray examination will be performed.
Before induction of anesthesia, an epidural catheter and an arterial canula for invasive blood pressure monitoring will be inserted. Immediately after induction of anesthesia and orotracheal intubation, all patients will be submitted to an alveolar recruitment maneuver (ARM) using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds. After ARM PEEP will be set to 6 cmH2O in the control group ("standard PEEP") and LPV will be performed. In the study group ("optimal PEEP") PEEP will be set to 14 cmH2O and a Cstat directed decremental PEEP titration procedure will be performed (every 4 minutes PEEP will be decreased by 2 cmH2O, until a final PEEP of 6 cmH2O) to determine the best individual PEEP. During surgery ARM will be repeated and arterial and central vein blood gas samples (ABGs, CVBGs) will be evaluated every 60 minutes. PCT levels will be measured 2, 6, 12, 24, 48 and 72 hours after surgical incision.
After extubation, patients will be addmitted to the Department of Anesthesiology and Intensive Care. ABGs and CVBGs will be collected and evaluated, PaO2/FiO2 and dCO2 will be calculated every 6 hours until 72 hours after surgery. On the first postoperative day chest X-ray will be performed and repeated on the following days if developing of pulmonary complications were suspected. Continuous epidural analgesia will be introduced, and evaluated effective if numeric pain rating scale point would be lower than 3 points.
During postoperative care continuous intraabdominal pressure (IAP) monitoring via a direct intraperitoneal catheter placed before closure of the abdominal wall will be performed to eliminate bias caused by the elevation of intraabdominal pressure.
Patients' clinical progress and secondary endpoints will be monitored by daily SOFA Scores, laboratory and physical examinations.
During follow-up period in-hospital stay, 28-days and in-hospital mortality will also be evaluated.
- Conditions
- Pulmonary Complications, Inflammatory Response
- Being tested
- Optimal PEEP, Standard PEEP
- Keywords
- Positive end-expiratory pressure, Static pulmonary compliance, Lung Protective Ventilation, Radical cystectomy and urinary diversion, Postoperative pulmonary complications, Procalcitonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal PEEPProcedure or surgery
Optimal PEEP determined by Cstat during PEEP titration procedure.
Standard PEEPProcedure or surgery
Lung protective mechanical ventilation applying a PEEP value of 6 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Optimal PEEP | Experimental | Patients submitted to general anesthesia and open radical cystectomy and urinary diversion (20 subjects) will be submitted an alveolar recruitment maneuver using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a decremental PEEP titration procedure directed by static pulmonary compliance (Cstat). During PEEP titration procedure PEEP will be decreased from 14 cmH2O by 2 cmH2O every 4 minutes, until a final PEEP of 6 cmH2O. Optimal PEEP is considered as a PEEP value resulting the highest possible Cstat measured by ventilator. After PEEP titration procedure a lung protective mechanical ventilation will be performed using optimal PEEP and low tidal volumes (6 mL/Kg IBW). Receives: Procedure: Optimal PEEP |
| Standard PEEP | Active comparator | Patients submitted to general anesthesia and open radical cystectomy and urinary diversion (20 subjects) will be submitted an alveolar recruitment maneuver using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a standard lung protective mechanical ventilation using a PEEP value of 6 cmH2O and low tidal volumes (6 mL/Kg). Receives: Procedure: Standard PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary Complications
New infiltrates or atelectasis on chest X-ray, abnormal breathing sounds on auscultation, excessive bronchial secretions, unexplained fever, respiratory failure defined as PaO2/FiO2 < 300 or need for non-invasive or invasive ventilatory support.
Measured: 72 hours
Procalcitonin Kinetics
Serum procalcitonin levels during and after surgery.
Measured: 72 hours
Secondary outcomes (5)
Incidence of Circulatory Failure
Severe hypotension, arrhytmias, decreased cardiac output, severe metabolic acidosis, congestive heart failure, acute coronary syndrome, pulmonary embolism and cardiac arrest.
Measured: 28 days
Incidence of Gastrointestinal Dysfunctions
Constipation or ileus, anastomotic leakage and need for urgent reoperation, disorders of liver function.
Measured: 28 days
Incidence of Renal Dysfunction
RIFLE Criteria
Measured: 28 days
Incidence of Hematologic and Coagulation Disorders
Severe bleeding and/or coagulopathy
Measured: 72 hours
Infection
Any infections except from pneumonia.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Péterfy Sándor Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Szeged University
- Responsible party
- Principal investigator, Dr. Zoltán Ruszkai, Péterfy Sándor Hospital
- Investigators
- Zsolt Molnár, Prof, MD, PhD, DEAA, Study director, University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive TherapyZoltán Ruszkai, MD, Principal investigator, Péterfy Sándor Hospital, Department of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931409
- Sponsor's protocol ID
- 21586-4/2016/EKU
- Other IDs
- CO-338-045, 149/2016-SZTE
- Status last verified
- Apr 2019
- First submitted
- 5 Oct 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD are not relevant in terms of results.
Publications
Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.
PubMed 32388650Ruszkai Z, Kiss E, Laszlo I, Gyura F, Surany E, Bartha PT, Bokretas GP, Racz E, Buzogany I, Bajory Z, Hajdu E, Molnar Z. Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial. Trials. 2017 Aug 11;18(1):375. doi: 10.1186/s13063-017-2116-z.
PubMed 28800778
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response. A Double-center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02931409
- Acronym / sponsor ID
- 21586-4/2016/EKU
- Conditions
- Pulmonary Complications, Inflammatory Response
- Keywords
- Positive end-expiratory pressure, Static pulmonary compliance, Lung Protective Ventilation, Radical cystectomy and urinary diversion, Postoperative pulmonary complications, Procalcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Péterfy Sándor HospitalUniversity, hospital or other
- Collaborators
- Szeged University
- Study start
- Oct 2016
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Oct 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.
The purpose of this prospective randomized controlled trial is to determine the effects of intraoperative lung protective mechanical ventilation using an individual optimal PEEP value on postoperative pulmonary complications and inflammatory response. A total number of 40 patients undergoing open radical cystectomy and urinary diversion will be enrolled and randomized into two groups. Standard lung protective ventilation using a PEEP of 6 cmH2O will be performed in control group and an optimal PEEP value determined during a static pulmonary compliance (Cstat) directed PEEP titration procedure will be applyed in study group. Low tidal volumes (6mL/Kg IBW) and a fraction of inspired oxygen (FiO2) of 0.5 will be applyed in both groups. Procalcitonin kinetics will be monitored during and after surgery until the third postoperative day as well as postoperative pulmonary complications. Clinical condition and extrapulmonary complications will be evaluated by the Sequential Organ Failure Assessment (SOFA) Score and in-hospital stay, 28-days and in-hospital mortality will also be followed.
Detailed description
Patients undergoing general anesthesia and mechanical ventilation during major abdominal surgery commonly develop pulmonary atelectasis or even hyperdistension of the lungs can occur leading to adverse consequences either intraoperatively or postoperatively. Lung protective ventilation (LPV, PEEP = 6 cmH2O, TV = 6 mL/Kg IBW and regular recruitments) during the intraoperative period can reduce the risk of ventilator induced lung injury (VILI) and prevent the formation of pulmonary atelectasis.
In our investigator-initiated, double-center, single-blinded, prospective, randomized, controlled clinical trial a total number of 40 patients with bladder cancer undergoing open radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) will be enrolled and randomized into two groups. Standard lung protective mechanical ventilation with the use of 6 cmH2O of PEEP and low tidal volumes (6mL/Kg IBW), a fraction of inspired oxygen (FiO2) of 0.5 and a respiratory rate to maintain an end tidal carbon dioxide (ETCO2) between 35-40 mmHg will be performed in control group, and a strategy of lung protective mechanical ventilation applying an optimal, individual PEEP determined by static pulmonary compliance (Cstat) directed PEEP titration procedure will be performed in study group.
During preoperative assessment, respiratory failure risk index (RFRI) will be recorded and informed consent will be obtained. Regarding to the protocol, a central vein catheter will be placed on the day before surgery, serum procalcitonin (PCT) level will be measured and a chest X-ray examination will be performed.
Before induction of anesthesia, an epidural catheter and an arterial canula for invasive blood pressure monitoring will be inserted. Immediately after induction of anesthesia and orotracheal intubation, all patients will be submitted to an alveolar recruitment maneuver (ARM) using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds. After ARM PEEP will be set to 6 cmH2O in the control group ("standard PEEP") and LPV will be performed. In the study group ("optimal PEEP") PEEP will be set to 14 cmH2O and a Cstat directed decremental PEEP titration procedure will be performed (every 4 minutes PEEP will be decreased by 2 cmH2O, until a final PEEP of 6 cmH2O) to determine the best individual PEEP. During surgery ARM will be repeated and arterial and central vein blood gas samples (ABGs, CVBGs) will be evaluated every 60 minutes. PCT levels will be measured 2, 6, 12, 24, 48 and 72 hours after surgical incision.
After extubation, patients will be addmitted to the Department of Anesthesiology and Intensive Care. ABGs and CVBGs will be collected and evaluated, PaO2/FiO2 and dCO2 will be calculated every 6 hours until 72 hours after surgery. On the first postoperative day chest X-ray will be performed and repeated on the following days if developing of pulmonary complications were suspected. Continuous epidural analgesia will be introduced, and evaluated effective if numeric pain rating scale point would be lower than 3 points.
During postoperative care continuous intraabdominal pressure (IAP) monitoring via a direct intraperitoneal catheter placed before closure of the abdominal wall will be performed to eliminate bias caused by the elevation of intraabdominal pressure.
Patients' clinical progress and secondary endpoints will be monitored by daily SOFA Scores, laboratory and physical examinations.
During follow-up period in-hospital stay, 28-days and in-hospital mortality will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal PEEP | Experimental | Procedure: Optimal PEEPPatients submitted to general anesthesia and open radical cystectomy and urinary diversion (20 subjects) will be submitted an alveolar recruitment maneuver using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a decremental PEEP titration procedure directed by static pulmonary compliance (Cstat). During PEEP titration procedure PEEP will be decreased from 14 cmH2O by 2 cmH2O every 4 minutes, until a final PEEP of 6 cmH2O. Optimal PEEP is considered as a PEEP value resulting the highest possible Cstat measured by ventilator. After PEEP titration procedure a lung protective mechanical ventilation will be performed using optimal PEEP and low tidal volumes (6 mL/Kg IBW). |
| Standard PEEP | Active comparator | Procedure: Standard PEEPPatients submitted to general anesthesia and open radical cystectomy and urinary diversion (20 subjects) will be submitted an alveolar recruitment maneuver using the sustained airway pressure by the CPAP method, applying 30 cmH2O PEEP for 30 seconds followed by a standard lung protective mechanical ventilation using a PEEP value of 6 cmH2O and low tidal volumes (6 mL/Kg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with bladder cancer undergoing radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute)
Key exclusion criteria (12 listed)
- Age < 18 years
- ASA grade IV
- History of severe chronic obstructive pulmonary disease (COPD, GOLD grade III or IV)
- History of severe or uncontrolled bronchial asthma
- History of severe restrictive pulmonary disease
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 |
|---|---|---|
| Optimal PEEPOptimal PEEP determined by Cstat during PEEP titration procedure. | Procedure or surgery | Optimal PEEP |
| Standard PEEPLung protective mechanical ventilation applying a PEEP value of 6 cmH2O | Procedure or surgery | Standard PEEP |
Primary outcome
Postoperative Pulmonary Complications
Time frame: 72 hours
New infiltrates or atelectasis on chest X-ray, abnormal breathing sounds on auscultation, excessive bronchial secretions, unexplained fever, respiratory failure defined as PaO2/FiO2 < 300 or need for non-invasive or invasive ventilatory support.
Procalcitonin Kinetics
Time frame: 72 hours
Serum procalcitonin levels during and after surgery.
5 secondary outcomes
Incidence of Circulatory Failure
Time frame: 28 days
Incidence of Gastrointestinal Dysfunctions
Time frame: 28 days
Incidence of Renal Dysfunction
Time frame: 28 days
Incidence of Hematologic and Coagulation Disorders
Time frame: 72 hours
Infection
Time frame: 28 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 2 Apr 2019.
- Derived from this study: PubMed 32388650Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.
- Derived from this study: PubMed 28800778Ruszkai Z, Kiss E, Laszlo I, Gyura F, Surany E, Bartha PT, Bokretas GP, Racz E, Buzogany I, Bajory Z, Hajdu E, Molnar Z. Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial. Trials. 2017 Aug 11;18(1):375. doi: 10.1186/s13063-017-2116-z.
- Individual participant dataSharing planned: No. IPD are not relevant in terms of results.
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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.
Zsolt Molnár, Prof, MD, PhD, DEAA study director
University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy
Zoltán Ruszkai, MD principal investigator
Péterfy Sándor Hospital, Department of Anaesthesiology and Intensive Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal PEEP and Standard PEEP in people with Pulmonary Complications and Inflammatory Response, run by Péterfy Sándor Hospital at 2 sites in Hungary.
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 12 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931409, which also lists 2 linked publications.
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 2 Apr 2019.