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

LOw versus COnventional Tidal Volumes during One–lung Ventilation for Minimally Invasive Esophagectomy – A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19986
Enrollment
30
Registered
2014-01-09
Start date
2014-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally invasive esophagectomy esophageal cancer lung protective ventilation small tidal volume ventilation minimaal invasieve oesophagus resectie oesofaguscarcinoom longproectief beademen kleine teug volumina beademing

Interventions

to use small tidal volumes during one lung ventilation

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients planned for elective minimally invasive esophagectomy for esophageal cancer after chemoradiation therapy

Exclusion criteria

Exclusion criteria: • Age 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
• Duration of postoperative mechanical ventilation • Length of stay in intensive care unit and hospital • Incidence of postoperative pulmonary complications • Intraoperative hypoxemia • Anastomotic leakage • Mortality

Contacts

Public ContactM.C.E. Woude, van der

Department of Intensive Care Medicine Atrium Medical Center Parkstad Henri Dunantstraat 5

m.vanderwoude@atriummc.nl+31-45-57667010

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)