NCT02931409

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

October 5, 2016

Last Update Submit

April 1, 2019

Conditions

Pulmonary ComplicationsInflammatory Response

Keywords

Positive end-expiratory pressureStatic pulmonary complianceLung Protective VentilationRadical cystectomy and urinary diversionPostoperative pulmonary complicationsProcalcitonin

Outcome Measures

Primary Outcomes (2)

  • 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.

    72 hours

  • Procalcitonin Kinetics

    Serum procalcitonin levels during and after surgery.

    72 hours

Secondary Outcomes (5)

  • Incidence of Circulatory Failure

    28 days

  • Incidence of Gastrointestinal Dysfunctions

    28 days

  • Incidence of Renal Dysfunction

    28 days

  • Incidence of Hematologic and Coagulation Disorders

    72 hours

  • Infection

    28 days

Other Outcomes (3)

  • ICU days

    28 days

  • In-hospital Stay

    28 days

  • Mortality

    28 days

Study Arms (2)

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).

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).

Procedure: Standard PEEP

Interventions

Optimal PEEPPROCEDURE

Optimal PEEP determined by Cstat during PEEP titration procedure.

Optimal PEEP
Standard PEEPPROCEDURE

Lung protective mechanical ventilation applying a PEEP value of 6 cmH2O

Standard PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with bladder cancer undergoing radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, 6722, Hungary

Location

Péterfy Sándor Hospital

Budapest, Pest County, 1076, Hungary

Location

Related Publications (2)

  • 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.

    PMID: 32388650DERIVED

  • Ruszkai 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.

    PMID: 28800778DERIVED

Study Officials

  • Zsolt Molnár, Prof, MD, PhD, DEAA

    University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy

    STUDY DIRECTOR

  • Zoltán Ruszkai, MD

    Péterfy Sándor Hospital, Department of Anaesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Department of Anaesthesiology and Intensive Care

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 13, 2016

Study Start

October 1, 2016

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

IPD are not relevant in terms of results.

Locations

HU(2)