Clinical trial NCT03256396: Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery
Official title: Intraoperative Positive End-Expiratory Pressure Setting Guided By Esophageal Pressure Measurement in Patients Undergoing Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive-Pressure Respiration/Methods
Esophagus/Physiopathology
Pleura/Physiopathology
Gynecologic Surgical Procedures
Laparoscopy
Humans
Female
Keywords: Intraoperative mechanical ventilation
Positive-end expiratory pressure
Esophageal pressure
Transpulmonary pressure
Laparoscopic gynecologic surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in PaO2 between Group E and Group C
timeFrame: At 15 minutes after initiation of pneumoperitoneum
measure: Difference in PaO2 between Group E and Group C
timeFrame: At 60 minutes after initiation of pneumoperitoneum
measure: Difference in PaO2 between Group E and Group C
timeFrame: At 30 minutes after arrival in recovery room
Secondary outcomes:
measure: Difference in compliance of respiratory system between Group E and Group C
timeFrame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
measure: Difference in alveolar dead space to tidal volume ratio between Group E and Group C
timeFrame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
measure: Difference in hemodynamics between Group E and Group C
timeFrame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
measure: Proportion of thoracoabdominal transmission of intraabdominal pressure
timeFrame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
measure: Adverse respiratory events
timeFrame: During 72 hours postoperatively or until discharge from hospital
measure: Length of hospital stay
timeFrame: Up to 30 days after the operation
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Annop Piriyapatsom, MD
role: PRINCIPAL_INVESTIGATOR
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