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…
ID
Bron
Verkorte titel
Aandoening
Minimally invasive esophagectomy
esophageal cancer
lung protective ventilation
small tidal volume ventilation
minimaal invasieve oesophagus resectie
oesofaguscarcinoom
longproectief beademen
kleine teug volumina beademing
Ondersteuning
fund = initiator = sponsor
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
to use small tidal volumes during one lung ventilation
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients planned for elective minimally invasive esophagectomy for esophageal cancer after chemoradiation therapy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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| Register | ID |
|---|---|
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| NTR-old | NTR4391 |
| Ander register | METC : 12-T-97 |