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Kleine versus GroteTeug Volumes gedurende Een- long Beademing voor Minimaal Invasieve Slokdarmverwijdering - Een Gerandomiseerd Gecontroleerd Onderzoek


- candidate number16011
- NTR NumberNTR4391
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jan-2014
- Secondary IDs12-T-97 METC
- Public TitleKleine versus GroteTeug Volumes gedurende Een- long Beademing voor Minimaal Invasieve Slokdarmverwijdering - Een Gerandomiseerd Gecontroleerd Onderzoek
- Scientific TitleLOw versus COnventional Tidal Volumes during One–lung Ventilation for Minimally Invasive Esophagectomy – A Randomized Controlled Trial
- ACRONYMLOCO-trial
- hypothesisWe hypothesize a lung–protective mechanical ventilation using lower tidal volumes during general anesthesia for minimally invasive transthoracic esophagectomy to protect against postoperative pulmonary complications in patients undergoing minimally invasive esophagectomy after radiation therapy.
- Healt Condition(s) or Problem(s) studiedMinimally invasive surgical procedures, Oesophagectomy, Esophageal cancer, Lung protective ventilation, Small tidal volume ventilation
- Inclusion criteriaPatients planned for elective minimally invasive esophagectomy for esophageal cancer after chemoradiation therapy
- Exclusion criteria• 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-jan-2015
- Target number of participants30
- Interventionsto use small tidal volumes during one lung ventilation
- Primary outcomeThe 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• Duration of postoperative mechanical ventilation • Length of stay in intensive care unit and hospital • Incidence of postoperative pulmonary complications • Intraoperative hypoxemia • Anastomotic leakage • Mortality
- TimepointsBefore, at the end of, and five days after surgery blood samples will be collected for measurement of: • Inflammatory mediators (cytokines, chemokines, other inflammatory proteins) • Markers of lung injury (surfactant proteins A and D) • Specific markers of distal organ injury (e.g., cystatin C, NGAL) • Assays for coagulation and fibrinolysis will be measured in the plasma supernatants and bronchoalveolar fluids.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.C.E. Woude, van der
- CONTACT for SCIENTIFIC QUERIESDrs. M.C.E. Woude, van der
- Sponsor/Initiator MAESTRO
- Funding
(Source(s) of Monetary or Material Support)
MAESTRO
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD9-jan-2014 - 31-mrt-2014


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