An interventional study of PEEP setting based on esophageal pressure measured in Positive-Pressure Respiration/Methods, Esophagus/Physiopathology and Pleura/Physiopathology, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. Intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.
As minimally invasive procedure with numerous advantages compared with open surgery, laparoscopic surgery has been substantially performed worldwide. The creation of pneumoperitoneum during laparoscopic surgery, however, can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. These pathophysiologic changes may put patients at risk of postoperative pulmonary complications. Therefore, intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. Nevertheless, there is no consensus on the optimal PEEP level and the best method to set PEEP during laparoscopic surgery. In patients with acute respiratory distress syndrome, PEEP set according to pleural pressure measured by using esophageal balloon catheter significantly has beneficial effects in terms of oxygenation, compliance and possible mortality. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.
Exclusion Criteria:
PEEP set according to esophageal pressure measured
Procedure: PEEP setting based on esophageal pressure measured
PEEP set at 5 cm H2O
PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O
Difference in PaO2 between Group E and Group C
Time frame: At 15 minutes after initiation of pneumoperitoneum
Difference in PaO2 between Group E and Group C
Time frame: At 60 minutes after initiation of pneumoperitoneum
Difference in PaO2 between Group E and Group C
Time frame: At 30 minutes after arrival in recovery room
Difference in compliance of respiratory system between Group E and Group C
Time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
Difference in alveolar dead space to tidal volume ratio between Group E and Group C
Time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
Difference in hemodynamics between Group E and Group C
Time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
Proportion of thoracoabdominal transmission of intraabdominal pressure
Time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
Adverse respiratory events
Adverse respiratory events define as requirement of oxygen supplement after discharge from the recovery room, episodes of desaturation (SpO2 of less than 90%), now-onset respiratory infection, new infiltration on chest radiograph, or respiratory failure.
Time frame: During 72 hours postoperatively or until discharge from hospital
Length of hospital stay
Time frame: Up to 30 days after the operation
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Mahidol University