Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery

NCT03256396 | Completed

• 1 other identifier: 253/2560(EC3)
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intraoperative mechanical ventilation; Positive-end expiratory pressure; Esophageal pressure; Transpulmonary pressure; Laparoscopic gynecologic surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (2)

Group E

EXPERIMENTAL

PEEP set according to esophageal pressure measured

Procedure: PEEP setting based on esophageal pressure measured

Group C

NO INTERVENTION

PEEP set at 5 cm H2O

Interventions

PEEP setting based on esophageal pressure measured PROCEDURE

PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O

Group E

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age of equal or more than 18 years old undergoing laparoscopic gynecologic surgery with anticipated surgical duration of more than 2 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (11)

• 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. doi: 10.1111/j.1365-2044.1996.tb07888.x.

  PMID: 8795317 BACKGROUND

• 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. doi: 10.1016/s0952-8180(01)00286-0.

  PMID: 11498317 BACKGROUND

• 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.

  PMID: 26643097 BACKGROUND

• 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. doi: 10.1016/j.bpa.2010.02.002.

  PMID: 20608559 BACKGROUND

• 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.

  PMID: 26895920 BACKGROUND

• 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.

  PMID: 19001507 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.2005.00713.x.

  PMID: 15954959 RESULT

• Maracaja-Neto LF, Vercosa 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.1399-6576.2008.01826.x.

  PMID: 19175578 RESULT

• 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 surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.

  PMID: 23196259 RESULT

• 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(6):855-61. doi: 10.1093/bja/aew123.

  PMID: 27199317 RESULT

• Piriyapatsom A, Phetkampang S. Effects of intra-operative positive end-expiratory pressure setting guided by oesophageal pressure measurement on oxygenation and respiratory mechanics during laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1032-1039. doi: 10.1097/EJA.0000000000001204.

  PMID: 32371830 DERIVED

Study Officials

• Annop Piriyapatsom, MD

  Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 22, 2017
• Study Start: March 30, 2018
• Primary Completion: June 29, 2018
• Study Completion: December 28, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)