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Clinical Trials/NCT03256396
NCT03256396CompletedNot Applicable

Intraoperative Positive End-Expiratory Pressure Setting Guided By Esophageal Pressure Measurement in Patients Undergoing Laparoscopic Gynecologic Surgery

Mahidol University2 sites in 1 country44 target enrollmentStarted: March 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Experimental

PEEP set according to esophageal pressure measured

Intervention: PEEP setting based on esophageal pressure measured (Procedure)

Group C

No Intervention

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Annop Piriyapatsom, MD

Lecturer, Department of Anesthesiology, Principal Investigator

Mahidol University

Study Sites (2)

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