The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics

March 8, 2023 updated by: Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Izmir, Turkey, 35150
        • Recruiting
        • KCU Izmir Atatürk Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • Murat Y Ozkalkanlı, M.D.
        • Sub-Investigator:
          • Derya A Yurtlu, M.D.
        • Sub-Investigator:
          • Ozgun Yılmaz, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing vertebral surgery in the prone position.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on lung compliance
Time Frame: 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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on heart rate
Time Frame: 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
3 months
Comparison of the effects of pressure-controlled volume guaranteed ventilation and volume-controlled ventilation on mean arterial pressure
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Ataturk Training and Research Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Izmir ATRH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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