Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

Not Applicable

Completed

• Conditions: Pleura/Physiopathology; Positive-Pressure Respiration/Methods; Female; Esophagus/Physiopathology; Gynecologic Surgical Procedures; Laparoscopy; Humans
• Interventions: Procedure: PEEP setting based on esophageal pressure measured

• Registration Number: NCT03256396
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Study Start: 2018-03-30
• Primary Completion: 2018-06-29
• Study Completion: 2018-12-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	PEEP setting based on esophageal pressure measured	PEEP set according to esophageal pressure measured

Primary Outcome Measures

Name	Time	Method
Difference in PaO2 between Group E and Group C	At 30 minutes after arrival in recovery room

Secondary Outcome Measures

Name	Time	Method
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
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	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.
Proportion of thoracoabdominal transmission of intraabdominal pressure	At 15 minutes and 60 minutes after initiation of pneumoperitoneum

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand