Hemodynamic Effects of Ventilation Modes

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03684291
• Other study ID #: HemodynamicsTrendelenburg
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: September 2018
• Source: Ufuk University
• Contact: Perihan Ekmekçi, MD
• Phone: +903122044000
• Email: erdogduperi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 15, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamics
• Laparoscopy
• Respiration, Artificial

Intervention

Procedure:
• Mode of Mechanical Ventilation
Adjustment of mechanical ventilation mode

Locations

Country	Name	City	State
Turkey	Ufuk University Faculty of Medicine	Ankara	Balgat

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in MAP	Mean arterial pressure (MAP) (mmHg)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Primary	Measurement of changes in heart rate	Heart rate (bpm)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Primary	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
Primary	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
Primary	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
Primary	Measurement of changes in stroke volume variation	Stroke volume variation (%)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Primary	Measurement of changes in cardiac cycle efficiency	Cardiac cycle efficiency (units)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Primary	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	Measurement of changes in peak airway pressure	Ppeak (Peak airway pressure)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Secondary	Measurement of changes in mean airway pressure	Pmean (Mean Airway Pressure),	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation
Secondary	Measurement of changes in plateau airway pressure	Pplateau (Plateau Airway Pressure)	T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation