Obesity
Conditions
Interventions
This is a randomized clinical trial with three single-blind groups. Randomization was performed using blocked randomization through the NCSS2021 software. A total of 78 patients will be randomized, wi
Phase B: PEEP of 10 cmH2O and Pinsp of 30 cmH2O for 5 breaths
Phase C: PEEP of 15 cmH2O and Pinsp of 35 cmH2O for 5 breaths
Phase D: PEEP of 20 cmH2O and Pinsp of 40 cmH2O for 10 breaths
PEEP titration will be performed as follows: With the mechanical ventilator in volume-controlled mode, with a tidal volume of 7 ml per kg of corrected weight and a respiratory rate of 15 bpm: Phase A:
Phase B: PEEP of 18 cmH2O for 5 breaths
Phase C: PEEP of 16 cmH2O for 5 breaths
Phase D: PEEP of 14 cmH2O for 5 brea
Sponsors
Saullo Queiroz Silveira
Universidade de São Paulo
Rede DOr
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals aged 18 to 65 years old; American Society of Anesthesiologists Physical Status Classification System 2 or 3; Body mass index = 30 Kg/m2; Elective laparoscopic bariatric surgery; Elective robotic bariatric surgery
Exclusion criteria
Exclusion criteria: American Society of Anesthesiologists Physical Status Classification System greater than or equal to 4; congestive heart failure; kidney failure; alcohol or drug abuse; allergy to study components; patients undergoing degastrectomy; patients undergoing combined surgeries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the impact of the recruitment maneuver associated with PEEP titration or the recruitment maneuver without PEEP titration on Driving Pressure at three time points: 5 minutes after intubation; 5 minutes after the installation of pneumoperitoneum and head-up position; 5 minutes after the removal of pneumoperitoneum. Driving pressure will be measured during the inspiratory pause in volume-controlled mode by subtracting PEEP from Driving Pressure. The outcome will be assessed in terms of the incidence of driving pressure above the threshold associated with the risk of lung injury (driving pressure greater than or equal to 15 cmH2O). A 20% reduction in the incidence of this outcome is expected. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the recruitment maneuver associated with PEEP titration will reduce the incidence of patients requiring supplementary oxygen in the Post-Anesthesia Care Unit (PACU) by 10% when compared to the other 2 study groups.;It is expected that the recruitment maneuver associated with PEEP titration will reduce the incidence of patients requiring supplementary oxygen upon discharge from the Post-Anesthesia Care Unit (PACU) by 20% when compared to the other 2 study groups.;It is expected that the recruitment maneuver associated with PEEP titration will reduce the incidence of postoperative pulmonary complications by 5% (included clinical diagnoses (pneumonia, bronchospasm, and/or acute respiratory distress syndrome), radiological diagnoses (presence of any degree or location of atelectasis,pneumothorax, and/or pleural effusion, and therapies for respiratory insufficiency (>1 day after end of surgery) supplemental oxygen, postoperative noninvasive ventilation (new to the patient or extended in time compared with the patient’s routine use), and/or reintubation with postoperativemechanical ventilation) during hospitalization when compared to the other 2 study groups.;It is expected that the recruitment maneuver associated with PEEP titration will increase by 20% the total dose of vasopressor used intraoperatively, measured in milligrams of metaraminol administered from intubation to extubation, with a standardized 0.5 mg bolus whenever the mean arterial pressure is below 65 mmHg when compared to the other 2 study groups.;It is expected that the recruitment maneuver associated with PEEP titration will reduce by 1 day the length of hospital stay, measured in days from the beginning of the surgery until hospital discharge when compared to the other 2 study groups. | — |
Countries
Brazil
Contacts
Public ContactSaullo Silveira
Universidade de São Paulo
Outcome results
None listed