Hemodynamic Effects of Ventilation Modes

NCT ID: NCT03684291

Last Updated: 2018-09-25

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-11-15

Brief Summary

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Different ventilation modes can be used in laparoscopic surgeries. These surgeries are performed in steep Trendelenburg position with serious hemodynamic disturbances. This study aims to observe the hemodynamic effects of two different ventilation modes in laparoscopic gynecologic surgery performed in steep Trendelenburg position.

Detailed Description

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Conditions

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Respiration, Artificial Laparoscopy Hemodynamics

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group V

The patients in this group are ventilated using VCV (Volume Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute, I/E ratio: 1/2, PEEP not applied)

Mode of Mechanical Ventilation

Intervention Type PROCEDURE

Adjustment of mechanical ventilation mode

Group P

The patients in this group are ventilated using PCV-VG (Volume Guaranteed Pressure Control Ventilation) mode (FiO2 50%, Tidal volume: 6-8 ml/kg (ideal body weight), frequency: 12/minute (EtCO2 kept between 35-40 mmHg), Pressure limit: 30 cm H2O, I/E:1/2, PEEP not applied)

Mode of Mechanical Ventilation

Intervention Type PROCEDURE

Adjustment of mechanical ventilation mode

Interventions

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Mode of Mechanical Ventilation

Adjustment of mechanical ventilation mode

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery

Exclusion Criteria

* Patient refusal to participate
* Patients with severe cardiac (congestive heart failure etc) and pulmonary (COPD, pulmonary hypertension) disease (ASA \> III)
* Morbid obesity
* Negative Allen test
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Hakan Yılmaz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ufuk University Faculty of Medicine

Ankara, Balgat, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Perihan Ekmekçi, MD

Role: CONTACT

+903122044000 ext. 4424

Facility Contacts

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Hakan Yılmaz, MD

Role: primary

+903122044000

References

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Balderi T, Forfori F, Marra V, Di Salvo C, Dorigo M, Anselmino M, Romano SM, Giunta F. Continuous hemodynamic monitoring during laparoscopic gastric bypass in superobese patients by pressure recording analytical method. Obes Surg. 2008 Aug;18(8):1007-14. doi: 10.1007/s11695-007-9379-5. Epub 2008 Apr 15.

Reference Type BACKGROUND
PMID: 18414959 (View on PubMed)

Liao CC, Kau YC, Ting PC, Tsai SC, Wang CJ. The Effects of Volume-Controlled and Pressure-Controlled Ventilation on Lung Mechanics, Oxidative Stress, and Recovery in Gynecologic Laparoscopic Surgery. J Minim Invasive Gynecol. 2016 Mar-Apr;23(3):410-7. doi: 10.1016/j.jmig.2015.12.015. Epub 2016 Jan 7.

Reference Type BACKGROUND
PMID: 26772778 (View on PubMed)

Other Identifiers

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HemodynamicsTrendelenburg

Identifier Type: -

Identifier Source: org_study_id

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