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

Respiratory System Abnormalities Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439801
• Other study ID #: GK5
• Status: Completed
• Phase: N/A
• First received: May 3, 2015
• Last updated: May 6, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory System Abnormalities

Intervention

Procedure:
• PEEP 0
0 cmH2O positive end expiratory pressure
• PEEP 5
5 cmH2O positive end expiratory pressure
• PEEP 8
8 cmH2O positive end expiratory pressure

Locations

Country	Name	City	State
Turkey	Istanbul Umraniye Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. 2014 Oct 13. doi: 10.1111/crj.12223. [Epub ahead of print] — View 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. — View Citation

Ozdilekcan C, Songur N, Berktas BM, Dinç M, Uçgül E, Ok U. Risk factors associated with postoperative pulmonary complications following oncological surgery. Tuberk Toraks. 2004;52(3):248-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of static-dynamic compliance with intra-operative PEEP treatment at 3 distinct levels		1 month	Yes
Secondary	elimination time of volatile anesthetic agent with intra-operative PEEP treatment at 3 distinct levels		1 month	Yes
Secondary	levels of p peak and p plateau pressures with intra-operative PEEP treatment at 3 distinct levels		1 month	Yes