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Clinical Trials/NCT03684291
NCT03684291
Unknown
Not Applicable

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

Ufuk University1 site in 1 country30 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiration, Artificial
Sponsor
Ufuk University
Enrollment
30
Locations
1
Primary Endpoint
Measurement of changes in MAP
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
November 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Ufuk University
Responsible Party
Principal Investigator
Principal Investigator

Hakan Yılmaz

Associate Professor

Ufuk University

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

Outcomes

Primary Outcomes

Measurement of changes in MAP

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Mean arterial pressure (MAP) (mmHg)

Measurement of changes in heart rate

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Heart rate (bpm)

Measurement of changes in systemic vascular resistance index

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Systemic vascular resistance index (dyne x sec/cm2)

Measurement of changes in stroke volume index

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Stroke volume index (mL/m2)

Measurement of changes in cardiac index

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Cardiac index L(min x m2)

Measurement of changes in stroke volume variation

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Stroke volume variation (%)

Measurement of changes in cardiac cycle efficiency

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Cardiac cycle efficiency (units)

Measurement of changes in aortic dp/dt

Time Frame: T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation

Aortic dP/dt (mmHg/msec)

Secondary Outcomes

  • Measurement of changes in peak airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)
  • Measurement of changes in mean airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)
  • Measurement of changes in plateau airway pressure(T0: Induction (Baseline) T1: Change after 30 minutes pneumoperitoneum T2: Change after desufflation)

Study Sites (1)

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