Clinical trial NCT03684291: Hemodynamic Effects of Ventilation Modes
Official title: Effects of Two Different Ventilation Modes Used in Gynecologic Laparoscopic Operations Performed in Steep Trendelenburg Position on Hemodynamic Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiration, Artificial
Laparoscopy
Hemodynamics
Keywords: Mechanical ventilation
Laparoscopic surgery
Hemodynamics
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 65 years of age scheduled to undergo elective gynecologic laparoscopic surgery

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of changes in MAP
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in heart rate
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in systemic vascular resistance index
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in stroke volume index
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in cardiac index
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in stroke volume variation
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in cardiac cycle efficiency
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in aortic dp/dt
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Secondary outcomes:
measure: Measurement of changes in peak airway pressure
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in mean airway pressure
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
measure: Measurement of changes in plateau airway pressure
timeFrame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Faculty of Medicine
state: Balgat
Study officials:
References:
citation: 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.
citation: 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.