Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT03256396

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Positive-Pressure Respiration/Methods Esophagus/Physiopathology Pleura/Physiopathology Gynecologic Surgical Procedures Laparoscopy Humans Female	Procedure: PEEP setting based on esophageal pressure measured	N/A

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

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 30, 2018

Actual Primary Completion Date :

Jun 29, 2018

Actual Study Completion Date :

Dec 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group E PEEP set according to esophageal pressure measured	Procedure: PEEP 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
No Intervention: Group C PEEP set at 5 cm H2O

Arm

Intervention/Treatment

Experimental: Group E

PEEP set according to esophageal pressure measured

Procedure: PEEP 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

No Intervention: Group C

PEEP set at 5 cm H2O

Outcome Measures

Primary Outcome Measures

Difference in PaO2 between Group E and Group C [At 15 minutes after initiation of pneumoperitoneum]
Difference in PaO2 between Group E and Group C [At 60 minutes after initiation of pneumoperitoneum]
Difference in PaO2 between Group E and Group C [At 30 minutes after arrival in recovery room]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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