Lung Diseases
Conditions
Interventions
The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with sp
59 patients) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2
59 patients).
Procedure/surgery
Sponsors
Hospital de Clinicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Adult patients ASA II to IV; age greater than 18 years; scheduled for arterial revascularization surgery on lower limbs.
Exclusion criteria
Exclusion criteria: Patients with body mass index above 40 kg/m2; patients undergoing emergency surgery; history of pulmonary surgery; persistent hemodynamic instability in the preoperative period; history of asthma or chronic use of corticotherapy; history of neuromuscular disorder; history of use of anticoagulants or antiplatelet agents in the preoperative period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pulmonary complications (primary composite outcome: mild respiratory failure / hypoxemia, severe respiratory failure, suspected lung infection, atelectasis, acute lung injury, barotrauma, pulmonary infiltrate, pleural effusion, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome - ARDS), diagnosed up to 7 days postoperatively in patients undergoing lower limb bypass surgery, based on clinical and/or radiological diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiovascular complications (secondary outcome composed of coronary syndromes events, non-fatal infarction and / or cardiogenic shock), diagnosed within 7 days after surgery in patients undergoing lower limb bypass surgery, based on radiological and/or clinical diagnosis;Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs), diagnosed within 7 days after surgery in patients undergoing lower limb bypass surgery, based on radiological and/or clinical diagnosis;Incidence of minor ventilatory complications related to the ventilation strategy (desaturation), assessed in the intraoperative period of patients undergoing lower limb bypass surgery, based on diagnosis by pulse oximetry;Perioperative pulmonary, gasometric and inflammatory physiological parameters, evaluated in patients undergoing lower limb bypass surgery, assessed by laboratory tests;Hemodynamic parameters, evaluated in the perioperative period of patients undergoing lower limb bypass surgery, based on multiparametric monitoring;Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the recovery room, and length of hospital stay, assessed in patients undergoing lower limb bypass surgery, based on clinical and laboratory diagnosis | — |
Countries
Brazil
Contacts
Public ContactAndré;Andre Schmidt;Schmidt
Hospital de Clinicas de Porto Alegre;Hospital de Clinicas de Porto Alegre
Outcome results
None listed