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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03684291
Other study ID # HemodynamicsTrendelenburg
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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