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
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Lower respiratory tract disorders (excl obstruction and infection)
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
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
Secondary endpoints include duration of postoperative mechanical ventilation,
length of stay in intensive care unit and hospital, incidence of postoperative
pulmonary complications and mortality.
Background summary
Minimally invasive transthoracic esophagectomy is a major surgical procedure
with a high risk of postoperative pulmonary complications. It is uncertain
whether mechanical ventilation plays a causative role in development of
postoperative pulmonary complications.
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
Randomized controlled trial
Study burden and risks
The burden for included patients will be minimal since patients will be
anesthetized when the bronchoscopy and broncheo alveolair lavage (BAL) takes
place. Also the blood samples will be taken during anesthesia (from an arterial
line).
The BAL is a very safe procedure with hardly no risks. There is a slight risk
of mucosal bleeding.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
patients who will undergo an esophagectomy
Exclusion criteria
Patients < 18 years
Patients with serious obstructive lung-disease
Patients with NYHA III or IV
Patients with chronic corticosteroid use
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 |
|---|---|
| CCMO | NL41619.096.12 |