Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary. \[initial setting\] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Suita, Osaka, Japan
RECRUITINGIncidence of hypoxia
SpO2 less than 95% or more than 2% decrease from baseline
Time frame: During laparoscopy procedure
Time to onset of hypoxia
Duration from the start of laparoscopic surgery to the onset of hypoxia
Time frame: During laparoscopy procedure
Rate of decrease in SpO2
Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery
Time frame: During laparoscopy procedure
Ventilator setting at the end of surgery
Ventilator settings such as FIO2, PEEP, and plateau pressure
Time frame: During surgery
compliance rate of lung recruitment
compliance rate of lung recruitment in the intevention group
Time frame: During laparoscopy procedure
Safety endpoint: Circulatory agonist use
Circulatory agonist use
Time frame: During surgery
Safety endpoint: total fluid infusion
total fluid infusion
Time frame: During surgery
Safety endpoint: incidence of complications
incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)
Time frame: During surgery
Postoperative hypoxia
Presence of hypoxia the day after surgery
Time frame: the day after surgery
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