The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics

Recruiting

• Conditions: Mechanical Ventilation
• Interventions: Device: The mechanical ventilation mode

• Registration Number: NCT05776589
• Lead Sponsor: Izmir Ataturk Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-25
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group PCV-VG	The mechanical ventilation mode	In this group, pressure-controlled volume guaranteed ventilation (PCV- VG) was applied in patients undergoing vertebral surgery in the prone position.
Group VCV	The mechanical ventilation mode	In this group, volume-controlled ventilation (VCV) was applied in patients undergoing vertebral surgery in the prone position.

Primary Outcome Measures

Name	Time	Method
Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on lung compliance	3 months	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

Secondary Outcome Measures

Name	Time	Method
Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on heart rate	3 months	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
Comparison of the effects of pressure-controlled volume guaranteed ventilation and volume-controlled ventilation on mean arterial pressure	3 months	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

Trial Locations

Locations (1)

KCU Izmir Atatürk Training and Research Hospital; 🇹🇷 Izmir, Turkey