No registrations found.
ID
Source
Brief title
Health condition
Minimally invasive esophagectomy
esophageal cancer
lung protective ventilation
small tidal volume ventilation
minimaal invasieve oesophagus resectie
oesofaguscarcinoom
longproectief beademen
kleine teug volumina beademing
Sponsors and support
fund = initiator = sponsor
Intervention
Outcome measures
Primary outcome
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
• Duration of postoperative mechanical ventilation
• Length of stay in intensive care unit and hospital
• Incidence of postoperative pulmonary complications
• Intraoperative hypoxemia
• Anastomotic leakage
• Mortality
Study objective
We 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.
Study design
Before, 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.
Intervention
to use small tidal volumes during one lung ventilation
Atrium Medical Center Parkstad
Henri Dunantstraat 5
M.C.E. Woude, van der
Heerlen 6419 PC
The Netherlands
+31-45-57667010
m.vanderwoude@atriummc.nl
Atrium Medical Center Parkstad
Henri Dunantstraat 5
M.C.E. Woude, van der
Heerlen 6419 PC
The Netherlands
+31-45-57667010
m.vanderwoude@atriummc.nl
Inclusion criteria
Patients 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4246 |
| NTR-old | NTR4391 |
| Other | METC : 12-T-97 |