Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256396
• Other study ID #: 253/2560(EC3)
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: December 28, 2018

Study information

• Verified date: August 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 28, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic — View Citation

Gallart L, Canet J. Post-operative pulmonary complications: Understanding definitions and risk assessment. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):315-30. doi: 10.1016/j.bpa.2015.10.004. Epub 2015 Oct 22. Review. Erratum in: Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):121-5. — View Citation

Maracajá-Neto LF, Verçosa N, Roncally AC, Giannella A, Bozza FA, Lessa MA. Beneficial effects of high positive end-expiratory pressure in lung respiratory mechanics during laparoscopic surgery. Acta Anaesthesiol Scand. 2009 Feb;53(2):210-7. doi: 10.1111/j — View Citation

Meininger D, Byhahn C, Mierdl S, Westphal K, Zwissler B. Positive end-expiratory pressure improves arterial oxygenation during prolonged pneumoperitoneum. Acta Anaesthesiol Scand. 2005 Jul;49(6):778-83. — View Citation

Park SJ, Kim BG, Oh AH, Han SH, Han HS, Ryu JH. Effects of intraoperative protective lung ventilation on postoperative pulmonary complications in patients with laparoscopic surgery: prospective, randomized and controlled trial. Surg Endosc. 2016 Oct;30(10):4598-606. doi: 10.1007/s00464-016-4797-x. Epub 2016 Feb 19. — View Citation

Pelosi P, Foti G, Cereda M, Vicardi P, Gattinoni L. Effects of carbon dioxide insufflation for laparoscopic cholecystectomy on the respiratory system. Anaesthesia. 1996 Aug;51(8):744-9. — View Citation

Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. — View Citation

Spadaro S, Karbing DS, Mauri T, Marangoni E, Mojoli F, Valpiani G, Carrieri C, Ragazzi R, Verri M, Rees SE, Volta CA. Effect of positive end-expiratory pressure on pulmonary shunt and dynamic compliance during abdominal surgery. Br J Anaesth. 2016 Jun;116 — View Citation

Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11. — View Citation

Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in PaO2 between Group E and Group C		At 15 minutes after initiation of pneumoperitoneum
Primary	Difference in PaO2 between Group E and Group C		At 60 minutes after initiation of pneumoperitoneum
Primary	Difference in PaO2 between Group E and Group C		At 30 minutes after arrival in recovery room
Secondary	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
Secondary	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
Secondary	Difference in hemodynamics between Group E and Group C		At 15 minutes and 60 minutes after initiation of pneumoperitoneum
Secondary	Proportion of thoracoabdominal transmission of intraabdominal pressure		At 15 minutes and 60 minutes after initiation of pneumoperitoneum
Secondary	Adverse respiratory events	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.	During 72 hours postoperatively or until discharge from hospital
Secondary	Length of hospital stay		Up to 30 days after the operation