Mechanical VentilationNCT05776589
The Effect of Intraoperative Ventilation Mode on Hemodynamics and Lung Dynamics
An observational study of Mechanical Ventilation, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- The mechanical ventilation mode
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing vertebral surgery in the prone position.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
KCU Izmir Atatürk Training and Research Hospital
Izmir, 35150
Derya a Yurtlu, M.D., +0902322444444, darslanyurtlu@yahoo.com
Murat Y Ozkalkanlı, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Mechanical Ventilation
- Being tested
- The mechanical ventilation mode
- Keywords
- lung dynamics under general anesthesia, prone position, pressure controlled mode, volume controlled mode, vertabral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mechanical ventilation modeDevice
Changing the mechanical ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| Group PCV-VG | In this group, pressure-controlled volume guaranteed ventilation (PCV- VG) was applied in patients undergoing vertebral surgery in the prone position. Receives: Device: The mechanical ventilation mode | |
| Group VCV | In this group, volume-controlled ventilation (VCV) was applied in patients undergoing vertebral surgery in the prone position. Receives: Device: The mechanical ventilation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital
- Investigators
- Derya A Yurtlu, M.D., Principal investigator, Izmir Atatürk Training and Reseach Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776589
- Sponsor's protocol ID
- Izmir ATRH
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05776589
- Acronym / sponsor ID
- Izmir ATRH
- Conditions
- Mechanical Ventilation
- Keywords
- lung dynamics under general anesthesia, prone position, pressure controlled mode, volume controlled mode, vertabral surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PCV-VG | – | Device: The mechanical ventilation modeIn this group, pressure-controlled volume guaranteed ventilation (PCV- VG) was applied in patients undergoing vertebral surgery in the prone position. |
| Group VCV | – | Device: The mechanical ventilation modeIn this group, volume-controlled ventilation (VCV) was applied in patients undergoing vertebral surgery in the prone position. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing vertebral surgery in the prone position.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The mechanical ventilation modeChanging the mechanical ventilation mode | Device | Group PCV-VG, Group VCV |
Primary outcome
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
2 secondary outcomes
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 and volume-controlled ventilation on mean arterial pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya A Yurtlu, M.D. principal investigator
Izmir Atatürk Training and Reseach Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation, run by Izmir Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derya A Yurtlu, M.D. (+0905058764132, darslanyurtlu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on lung compliance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.