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

NCT02439801 | Completed

• 1 other identifier: GK5
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory System Abnormalities

Keywords

PEEP; compliance; peak airway pressures

Outcome Measures

Primary Outcomes (1)

• levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels

  1 month

Secondary Outcomes (2)

• 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

Study Arms (3)

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; Procedure: PEEP 5; Procedure: PEEP 8

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; Procedure: PEEP 5; Procedure: PEEP 8

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; Procedure: PEEP 5; Procedure: PEEP 8

Interventions

PEEP 0 PROCEDURE

0 cmH2O positive end expiratory pressure

Compliance; Pulmonary Function tests; volatil agent elimination time

PEEP 5 PROCEDURE

5 cmH2O positive end expiratory pressure

Compliance; Pulmonary Function tests; volatil agent elimination time

PEEP 8 PROCEDURE

8 cmH2O positive end expiratory pressure

Compliance; Pulmonary Function tests; volatil agent elimination time

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who will undergo for elective laparoscopic cholecystectomy

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 23877309 RESULT

• 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.

  PMID: 25307158 RESULT

• 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.

  PMID: 15351938 RESULT

MeSH Terms

Conditions

Respiratory System Abnormalities; Patient Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nurten Bakan, MD

  Unraniye training hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

TU (1)