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

NCT ID: NCT02439801

Last Updated: 2015-05-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Respiratory System Abnormalities

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PEEP 0

Intervention Type PROCEDURE

0 cmH2O positive end expiratory pressure

PEEP 5

Intervention Type PROCEDURE

5 cmH2O positive end expiratory pressure

PEEP 8

Intervention Type PROCEDURE

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.

PEEP 0

Intervention Type PROCEDURE

0 cmH2O positive end expiratory pressure

PEEP 5

Intervention Type PROCEDURE

5 cmH2O positive end expiratory pressure

PEEP 8

Intervention Type PROCEDURE

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.

PEEP 0

Intervention Type PROCEDURE

0 cmH2O positive end expiratory pressure

PEEP 5

Intervention Type PROCEDURE

5 cmH2O positive end expiratory pressure

PEEP 8

Intervention Type PROCEDURE

8 cmH2O positive end expiratory pressure

Interventions

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PEEP 0

0 cmH2O positive end expiratory pressure

Intervention Type PROCEDURE

PEEP 5

5 cmH2O positive end expiratory pressure

Intervention Type PROCEDURE

PEEP 8

8 cmH2O positive end expiratory pressure

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gulsah Karaoren

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten Bakan, MD

Role: STUDY_DIRECTOR

Unraniye training hospital

Locations

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Istanbul Umraniye Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23877309 (View on PubMed)

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.

Reference Type RESULT
PMID: 25307158 (View on PubMed)

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.

Reference Type RESULT
PMID: 15351938 (View on PubMed)

Other Identifiers

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GK5

Identifier Type: -

Identifier Source: org_study_id

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