Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery
NCT ID: NCT03256396
Last Updated: 2019-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2018-03-30
2018-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group E
PEEP set according to esophageal pressure measured
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
Group C
PEEP set at 5 cm H2O
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Annop Piriyapatsom, MD
Lecturer, Department of Anesthesiology, Principal Investigator
Principal Investigators
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Annop Piriyapatsom, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Locations
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Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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253/2560(EC3)
Identifier Type: -
Identifier Source: org_study_id
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