Hemodynamic Effects of Ventilation Modes

Effects of Two Different Ventilation Modes Used in Gynecologic Laparoscopic Operations Performed in Steep Trendelenburg Position on Hemodynamic Parameters

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopy; Respiration, Artificial; Hemodynamics
• Intervention / Treatment: Procedure: Mode of Mechanical Ventilation

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Turkey
  • Balgat
    • Ankara, Balgat, Turkey, 06520
      • Recruiting
      • UFUK UNIVERSITY FACULTY OF MEDICINE
      • Contact: Hakan Yılmaz, MD; Phone Number: +903122044000; Email: dr.hakanyilmaz@hotmail.com
      • Principal Investigator: Hakan Yılmaz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18 and 65 years of age scheduled to undergo elective gynecologic laparoscopic surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Procedure: Mode of Mechanical Ventilation; 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)	Procedure: Mode of Mechanical Ventilation; Adjustment of mechanical ventilation mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of changes in MAP	Mean arterial pressure (MAP) (mmHg)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in heart rate	Heart rate (bpm)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in systemic vascular resistance index	Systemic vascular resistance index (dyne x sec/cm2)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in stroke volume index	Stroke volume index (mL/m2)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in cardiac index	Cardiac index L(min x m2)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in stroke volume variation	Stroke volume variation (%)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in cardiac cycle efficiency	Cardiac cycle efficiency (units)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in aortic dp/dt	Aortic dP/dt (mmHg/msec)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of changes in peak airway pressure	Ppeak (Peak airway pressure)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in mean airway pressure	Pmean (Mean Airway Pressure),	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Measurement of changes in plateau airway pressure	Pplateau (Plateau Airway Pressure)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Collaborators and Investigators

• Sponsor: Ufuk University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 15, 2018

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Hemodynamics; Mechanical ventilation
• Other Study ID Numbers: HemodynamicsTrendelenburg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No