Comparison of Effects of PEEP Levels on Respiratory Mechanics in Patients Undergoing Laparoscopic Cholecystectomy

Comparison of Effects of 3 Different PEEP Levels on Hemodynamic, Respiratory Mechanics and Elimination of Volatile Anesthetic Agent in Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Respiratory System Abnormalities
• Intervention / Treatment: Procedure: PEEP 0; Procedure: PEEP 5; Procedure: PEEP 8

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Umraniye Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who will undergo for elective laparoscopic cholecystectomy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Compliance; Pulmonary compliance (or lung compliance) is a measure of the lung's ability to stretch and expand. In clinical practice it is separated into two different measurements, static compliance and dynamic compliance. Static lung compliance is the change in volume for any given applied pressure. Dynamic lung compliance is the compliance of the lung at any given time during actual movement of air. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on static and dynamic compliance levels will be investigate.	Procedure: PEEP 0; 0 cmH2O positive end expiratory pressure; Procedure: PEEP 5; 5 cmH2O positive end expiratory pressure; Procedure: PEEP 8; 8 cmH2O positive end expiratory pressure
Pulmonary Function tests; Pulmonary function testing has diagnostic and therapeutic roles and helps clinicians answer some general questions about patients with lung disease. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on pulmonary function test values will be investigate.	Procedure: PEEP 0; 0 cmH2O positive end expiratory pressure; Procedure: PEEP 5; 5 cmH2O positive end expiratory pressure; Procedure: PEEP 8; 8 cmH2O positive end expiratory pressure
volatil agent elimination time; Volatile anaesthetics are eliminated in the terminal phase via the lungs. A low blood:gas partition coefficient is therefore necessary for quick removal of the anaesthetic. Effects of intra-operative PEEP 0, PEEP 5, PEEP 8 treatment on volatil agent elimination time will be investigate.	Procedure: PEEP 0; 0 cmH2O positive end expiratory pressure; Procedure: PEEP 5; 5 cmH2O positive end expiratory pressure; Procedure: PEEP 8; 8 cmH2O positive end expiratory pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels	1 month
levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels	1 month

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Study Director: Nurten Bakan, MD, Unraniye training hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 3, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: compliance; PEEP; peak airway pressures
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Congenital Abnormalities; Respiratory System Abnormalities
• Other Study ID Numbers: GK5