Kleine versus GroteTeug Volumes gedurende Een- long Beademing voor Minimaal Invasieve Slokdarmverwijdering - Een Gerandomiseerd Gecontroleerd Onderzoek
- Conditions
- Minimally invasive esophagectomyesophageal cancerlung protective ventilationsmall tidal volume ventilationminimaal invasieve oesophagus resectieoesofaguscarcinoomlongproectief beademenkleine teug volumina beademing
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Patients planned for elective minimally invasive esophagectomy for esophageal cancer after chemoradiation therapy
•Age < 18 years
•Body mass index > 40 kg/m2
•Chronic obstructive pulmonary disease with a FEV1 of less than 65%
•Preoperative systemic corticosteroid therapy
•Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia’s)
•Altered liver function (Child-Pugh class B or more)
•Neuromuscular disease (any)
•Suspected acute pulmonary infection: In case patient receives antibiotics and meets at least one of the following criteria: new or changed sputum, new or changed lung opacities on chest X–ray when clinically indicated, tympanic temperature > 38.30C, WBC count > 12,000/mm3
•Consented for another interventional study or refusal to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoints of this study are markers of pulmonary inflammation and coagulation, including cytokines and chemokines, neutrophil influx, markers of apoptosis, and markers of coagulation and fibrinolysis in lavage fluids obtained at the beginning and at the end of surgery.
- Secondary Outcome Measures
Name Time Method •Duration of postoperative mechanical ventilation <br>•Length of stay in intensive care unit and hospital<br>•Incidence of postoperative pulmonary complications<br>•Intraoperative hypoxemia<br>•Anastomotic leakage<br>•Mortality<br>