Clinical trial NCT02439801: Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory System Abnormalities
Keywords: PEEP
compliance
peak airway pressures
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-05-12
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will undergo for elective laparoscopic cholecystectomy

Brief summary: Laparoscopic cholecystectomy is accepted as gold standard in the management of cholelithiasis. Although laparoscopic procedures have many advantages,intra-abdominal CO2 insufflation can cause decreased lung volumes and compliance, increased airway resistance and impaired ventilation-perfusion ratio. In this study, investigators aim to investigate effects of intra-operative PEEP treatment at 3 distinct levels on respiratory dynamics and elimination time of volatile anesthetic agent.

Detailed description: In the study, 75 ASA I-II patients aged 30-65 years will be randomized into 3 groups to receive 0 cmH2O PEEP (Group-1), 5 cmH2O PEEP (Group-2) and 8 cmH2O PEEP (Group-3) in PVC mode. In all patients underwent general anesthesia; hemodynamic parameters, Ppeak, Pplateau, compliance values as well as Fisevo/Fexpsevo ratio at 1 MAC and times from 1 MAC to 0.3 and 0.1 MAC will be recorded. In addition, preoperative and postoperative pulmonary function tests will be compared in all patients.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I-II
* BMI of 25-30
* patients scheduled to elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patients with ASA III, IV, V risk,
* Patients with comorbid diseases that may increase intra-abdominal pressure or pulmonary hypertension,
* Patients with renal and hepatic failure,
* Patients with pregnancy and
* Patients using bronchodilator or steroid were excluded.

Primary outcomes:
measure: levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels
timeFrame: 1 month
Secondary outcomes:
measure: elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels
timeFrame: 1 month
measure: levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Umraniye Training Hospital
Study officials:
affiliation: Unraniye training hospital
name: Nurten Bakan, MD
role: STUDY_DIRECTOR
References:
citation: Karsten J, Heinze H, Meier T. Impact of PEEP during laparoscopic surgery on early postoperative ventilation distribution visualized by electrical impedance tomography. Minerva Anestesiol. 2014 Feb;80(2):158-66. Epub 2013 Jul 23.
citation: Aydin V, Kabukcu HK, Sahin N, Mesci A, Arici AG, Kahveci G, Ozmete O. Comparison of pressure and volume-controlled ventilation in laparoscopic cholecystectomy operations. Clin Respir J. 2016 May;10(3):342-9. doi: 10.1111/crj.12223. Epub 2014 Nov 14.
citation: Ozdilekcan C, Songur N, Berktas BM, Dinc M, Ucgul E, Ok U. Risk factors associated with postoperative pulmonary complications following oncological surgery. Tuberk Toraks. 2004;52(3):248-55.