The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics

Mechanical Ventilation Clinical Trial

Official title:

The Effect of Pressure Controlled Volume Guaranteed Ventilation and Volume Controlled Ventilation on Hemodynamics and Lung Dynamics in Prone Position Patients in Thoracolomber Vertebra Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776589
• Other study ID #: Izmir ATRH
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Izmir Ataturk Training and Research Hospital
• Contact: Derya A Yurtlu, M.D.
• Phone: +0905058764132
• Email: darslanyurtlu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, it was aimed to compare the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on lung dynamics and hemodynamics in patients undergoing vertebral surgery in the prone position.

Description:

The VCV (volume controlled ventilation) mode is the mode commonly used in general anesthesia practice. In VCV mode, the parameters under control are tidal volume and respiratory rate. In VCV mode, airway pressure changes depending on resistance and compliance. There is a risk of increased airway pressures in this mode.

In PCV-VG (pressure controlled volume guaranteed ventilation) mode, the parameters under control are the peak airway inspiratory pressure and the I/E ratio. It has been shown that peak airway pressures decrease and partial oxygen pressure increase due to decreased inspiratory flow in this ventilation mode.

Both ventilation modes are frequently used in patients undergoing general anesthesia.

In this study, it was aimed to compare the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on lung dynamics (pulmonary peak-plateau pressure, compliance, driving pressure, SpO2 and end-tidal carbon dioxide) and hemodynamics (mean arterial pressure and heart rate) in patients undergoing vertebral surgery in the prone position.

In the study, patients will be randomized and divided into 2 groups after obtaining informed consent forms. If a mode change is required during the surgery, that patient will be excluded from the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who will undergo thoracolumbar vertebral surgery in the prone position

• Patients older than 18 years

• Patients younger than 70 years of age

• ASA 1-2 patients

Exclusion Criteria:

• Patients with a BMI >30 kg/m2

• Patients with a history of chronic pulmonary disease

• Patients with a history of previous thoracic surgery

• Patients with ASA >3

• Patients who will undergo emergency surgery

• Pregnant patients

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Device:
• The mechanical ventilation mode
Changing the mechanical ventilation mode

Locations

Country	Name	City	State
Turkey	KCU Izmir Atatürk Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Ataturk Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on lung compliance	Comparison of the effects of pressure controlled volume guaranteed ventilation (PCV-VG) and volume controlled ventilation (VCV) on lung compliance (ml/cmH20) in patients undergoing vertebral surgery in a prone position	3 months
Secondary	Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on heart rate	Comparison of the effects of pressure controlled volume guaranteed ventilation (PCV-VG) and volume controlled ventilation (VCV) on heart beats per minute (bpm) in patients undergoing vertebral surgery in a prone position	3 months
Secondary	Comparison of the effects of pressure-controlled volume guaranteed ventilation and volume-controlled ventilation on mean arterial pressure	Comparison of the effects of pressure controlled volume guaranteed ventilation (PCV-VG) and volume controlled ventilation (VCV) on mean arterial pressure (mmHg) in patients undergoing vertebral surgery in a prone position	3 months