Esophagus/Physiopathology, Female, Gynecologic Surgical Procedures, Humans, Laparoscopy, Pleura/Physiopathology, Positive-Pressure Respiration/Methods
Conditions
Keywords
Intraoperative mechanical ventilation, Positive-end expiratory pressure, Esophageal pressure, Transpulmonary pressure, Laparoscopic gynecologic surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPEEP setting based on esophageal pressure measured
PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with age of equal or more than 18 years old undergoing laparoscopic gynecologic surgery with anticipated surgical duration of more than 2 hours
Exclusion criteria
* Patients with ASA physical status of equal or more than 3 * Patients with significant cardiovascular or respiratory diseases * Patients with significant pathological lesion in pharynx and esophagus that preclude placement of esophageal balloon catheter * Patients with contraindications for PEEP titration such as increased intracranial pressure or unstable hemodynamic * Patients with arrhythmias * Patients who refuse to provide written informed consent * Patients undergoing surgery with duration of less than 2 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in PaO2 between Group E and Group C | At 15 minutes after initiation of pneumoperitoneum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in compliance of respiratory system between Group E and Group C | 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 | 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 | At 15 minutes and 60 minutes after initiation of pneumoperitoneum | — |
| Proportion of thoracoabdominal transmission of intraabdominal pressure | At 15 minutes and 60 minutes after initiation of pneumoperitoneum | — |
| Adverse respiratory events | During 72 hours postoperatively or until discharge from hospital | 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. |
| Length of hospital stay | Up to 30 days after the operation | — |
Countries
Thailand
Outcome results
None listed