Hemodynamic Effects of Ventilation Modes

NCT03684291 | Unknown DMC

• 1 other identifier: HemodynamicsTrendelenburg
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration, Artificial; Laparoscopy; Hemodynamics

Keywords

Mechanical ventilation; Laparoscopic surgery; Hemodynamics

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• 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 Arms (2)

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

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

Interventions

Mode of Mechanical Ventilation PROCEDURE

Adjustment of mechanical ventilation mode

Group P; Group V

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Observations will be performed in laparoscopic gynecological operations
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women of ASA I and II classification between 18-65 years scheduled for elective gynecologic laparoscopic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University Faculty of Medicine

Ankara, Balgat, 06520, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 18414959 BACKGROUND

• 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.

  PMID: 26772778 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Perihan Ekmekçi, MD

CONTACT

+903122044000; erdogduperi@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: September 25, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 15, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)