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Trial record 5 of 5 for:    20608559 [PUBMED-IDS]

Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT03256396
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Annop Piriyapatsom, MD, 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.

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 31, 2018
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : October 31, 2018

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



Primary Outcome Measures :
  1. Difference in PaO2 between Group E and Group C [ Time Frame: At 15 minutes after initiation of pneumoperitoneum ]
  2. Difference in PaO2 between Group E and Group C [ Time Frame: At 60 minutes after initiation of pneumoperitoneum ]
  3. Difference in PaO2 between Group E and Group C [ Time Frame: At 30 minutes after arrival in recovery room ]

Secondary Outcome Measures :
  1. Difference in compliance of respiratory system between Group E and Group C [ Time Frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room ]
  2. Difference in alveolar dead space to tidal volume ratio between Group E and Group C [ Time Frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room ]
  3. Difference in hemodynamics between Group E and Group C [ Time Frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum ]
  4. Proportion of thoracoabdominal transmission of intraabdominal pressure [ Time Frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum ]
  5. Adverse respiratory events [ Time Frame: 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.

  6. Length of hospital stay [ Time Frame: Up to 30 days after the operation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256396


Contacts
Contact: Annop Piriyapatsom, MD +66 9 2281 9241 annop.pir@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Annop Piriyapatsom, MD    +669 2281 9241    annop.pir@mahidol.ac.th   
Contact: Sanchai Phetkampang, MD    +668 1688 8581    sanchai.boat@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Annop Piriyapatsom, MD Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
  Study Documents (Full-Text)

Documents provided by Annop Piriyapatsom, MD, Mahidol University:

Publications of Results:
Other Publications:
Responsible Party: Annop Piriyapatsom, MD, Lecturer, Department of Anesthesiology, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03256396     History of Changes
Other Study ID Numbers: 253/2560(EC3)
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annop Piriyapatsom, MD, Mahidol University:
Intraoperative mechanical ventilation
Positive-end expiratory pressure
Esophageal pressure
Transpulmonary pressure
Laparoscopic gynecologic surgery