Inflammatory Response Clinical Trial
Official title:
Intraoperative PEEP Optimization: Effects on Postoperative Pulmonary Complications and Inflammatory Response. A Double-center, Prospective, Randomized Controlled Trial
Verified date | April 2019 |
Source | Péterfy Sándor Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with bladder cancer undergoing radical cystectomy and urinary diversion (ileal conduit or orthotopic bladder substitute) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hungary | Péterfy Sándor Hospital | Budapest | Pest |
Hungary | University of Szeged, Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy | Szeged | Csongrád |
Lead Sponsor | Collaborator |
---|---|
Péterfy Sándor Hospital | Szeged University |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ICU days | Defined as a period from the first postoperative day until emission from the ICU. | 28 days | |
Other | In-hospital Stay | From the day of surgery until emission from hospital. | 28 days | |
Other | Mortality | In-hospital and 28 days mortality. | 28 days | |
Primary | 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 | |
Primary | Procalcitonin Kinetics | Serum procalcitonin levels during and after surgery. | 72 hours | |
Secondary | Incidence of Circulatory Failure | Severe hypotension, arrhytmias, decreased cardiac output, severe metabolic acidosis, congestive heart failure, acute coronary syndrome, pulmonary embolism and cardiac arrest. | 28 days | |
Secondary | Incidence of Gastrointestinal Dysfunctions | Constipation or ileus, anastomotic leakage and need for urgent reoperation, disorders of liver function. | 28 days | |
Secondary | Incidence of Renal Dysfunction | RIFLE Criteria | 28 days | |
Secondary | Incidence of Hematologic and Coagulation Disorders | Severe bleeding and/or coagulopathy | 72 hours | |
Secondary | Infection | Any infections except from pneumonia. | 28 days |
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