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Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

M

Mahidol University

Status

Completed

Conditions

Laparoscopy
Humans
Female
Gynecologic Surgical Procedures
Positive-Pressure Respiration/Methods
Esophagus/Physiopathology
Pleura/Physiopathology

Treatments

Procedure: PEEP setting based on esophageal pressure measured

Study type

Interventional

Funder types

Other

Identifiers

NCT03256396
253/2560(EC3)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Group E
Experimental group
Description:
PEEP set according to esophageal pressure measured
Treatment:
Procedure: PEEP setting based on esophageal pressure measured
Group C
No Intervention group
Description:
PEEP set at 5 cm H2O

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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