Intraoperative Positive End-Expiratory Pressure Setting Guided By Esophageal Pressure Measurement in Patients Undergoing Laparoscopic Gynecologic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Difference in PaO2 between Group E and Group C
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Group E
PEEP set according to esophageal pressure measured
Intervention: PEEP setting based on esophageal pressure measured (Procedure)
Group C
PEEP set at 5 cm H2O
Outcomes
Primary Outcomes
Difference in PaO2 between Group E and Group C
Time Frame: At 30 minutes after arrival in recovery room
Secondary Outcomes
- Difference in hemodynamics between Group E and Group C(At 15 minutes and 60 minutes after initiation of pneumoperitoneum)
- Length of hospital stay(Up to 30 days after the operation)
- Proportion of thoracoabdominal transmission of intraabdominal pressure(At 15 minutes and 60 minutes after initiation of pneumoperitoneum)
- 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)
- Adverse respiratory events(During 72 hours postoperatively or until discharge from hospital)
Investigators
Annop Piriyapatsom, MD
Lecturer, Department of Anesthesiology, Principal Investigator
Mahidol University