The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics

• Sponsor: Izmir Ataturk Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05776589
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Anticipated Duration (Months): 2.9
• Patients Per Site Per Month: 24.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation	Device: The mechanical ventilation mode

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 Design

• Study Type: Observational
• Anticipated Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group PCV-VG In this group, pressure-controlled volume guaranteed ventilation (PCV- VG) was applied in patients undergoing vertebral surgery in the prone position.	Device: The mechanical ventilation mode; Changing the mechanical ventilation mode
Group VCV In this group, volume-controlled ventilation (VCV) was applied in patients undergoing vertebral surgery in the prone position.	Device: The mechanical ventilation mode; Changing the mechanical ventilation mode

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KCU Izmir Atatürk Training and Research Hospital	Izmir		Turkey	35150

Sponsors and Collaborators

• Izmir Ataturk Training and Research Hospital

Investigators

• Principal Investigator: Derya A Yurtlu, M.D., Izmir Atatürk Training and Reseach Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Derya Arslan Yurtlu, Associate Professor, Izmir Ataturk Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05776589
• Other Study ID Numbers: Izmir ATRH
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Derya Arslan Yurtlu, Associate Professor, Izmir Ataturk Training and Research Hospital: lung dynamics under general anesthesia; prone position; pressure controlled mode; volume controlled mode; vertabral surgery

Study Results

No Results Posted as of Mar 20, 2023