Vocal Cord DiseaseNCT06493162
Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation
A study testing Intubation in people with Vocal Cord Disease and Vocal Cord Cyst, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vocal Cord Disease, Vocal Cord Cyst
- What is being tested?
- Intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Feb 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective microscopic laser surgery
- ASA status I and II
Who cannot join
- Surgery time more than 2 hours
- Patients with difficult intubation
- Patients with chronic lung diseases
- BMI > 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial
Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times.
Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred.
For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.
- Conditions
- Vocal Cord Disease, Vocal Cord Cyst
- Being tested
- Intubation, Flow Controlled Ventilation, Volume Controlled Ventilation
- Keywords
- Microscopic Laryngeal Surgery, Flow Controlled Ventilation, Volume Controlled Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationProcedure or surgery
Patients will be intubated with 5mm sized endotracheal tube for microscopic laryngeal surgery
Flow Controlled VentilationDevice
Patients in FCV group will be ventilated with flow controlled ventilation mode
Volume Controlled VentilationDevice
Patients in VCV group will be ventilated with volume controlled ventilation mode
| Study group | Role | What they receive |
|---|---|---|
| FCV Group | Active comparator | Patients who will be ventilated with flow controlled ventilation following the intubation Receives: Procedure: Intubation; Device: Flow Controlled Ventilation |
| VCV Group | Active comparator | Patients who will be ventilated with volume controlled ventilation following the intubation Receives: Procedure: Intubation; Device: Volume Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIP
Peak inspiratory pressure
Measured: 10 minutes interval after the intubation during the surgery
RR
Respiratory rate
Measured: 10 minutes interval after the intubation during the surgery
TV
Tidal volume
Measured: 10 minutes interval after the intubation during the surgery
Compliance (Cdyn)
Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)
Measured: 10 minutes interval after the intubation during the surgery
Resistance
Resistance (ventilator calculates: dividing the [peak pressure minus the plateau pressure] by the flowrate in litres per second)
Measured: 10 minutes interval after the intubation during the surgery
Secondary outcomes (3)
HR
Heart rate
Measured: 10 minutes interval after the intubation during the surgery
MP
Mean blood pressure
Measured: 10 minutes interval after the intubation during the surgery
SpO2
Oxygen saturation
Measured: 10 minutes interval after the intubation during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Aug 2024
- Primary completion15 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Ufuk Yörükoğlu, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493162
- Sponsor's protocol ID
- KAEK/05.bI.07
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06493162
- Acronym / sponsor ID
- KAEK/05.bI.07
- Conditions
- Vocal Cord Disease, Vocal Cord Cyst
- Keywords
- Microscopic Laryngeal Surgery, Flow Controlled Ventilation, Volume Controlled Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Jul 2024 (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.
Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times.
Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred.
For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCV Group | Active comparator | Procedure: Intubation, Device: Flow Controlled VentilationPatients who will be ventilated with flow controlled ventilation following the intubation |
| VCV Group | Active comparator | Procedure: Intubation, Device: Volume Controlled VentilationPatients who will be ventilated with volume controlled ventilation following the intubation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who undergo elective microscopic laser surgery
- ASA status I and II
Key exclusion criteria (4 listed)
- Surgery time more than 2 hours
- Patients with difficult intubation
- Patients with chronic lung diseases
- BMI > 25
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 |
|---|---|---|
| IntubationPatients will be intubated with 5mm sized endotracheal tube for microscopic laryngeal surgery | Procedure or surgery | FCV Group, VCV Group |
| Flow Controlled VentilationPatients in FCV group will be ventilated with flow controlled ventilation mode | Device | FCV Group |
| Volume Controlled VentilationPatients in VCV group will be ventilated with volume controlled ventilation mode | Device | VCV Group |
Primary outcome
PIP
Time frame: 10 minutes interval after the intubation during the surgery
Peak inspiratory pressure
RR
Time frame: 10 minutes interval after the intubation during the surgery
Respiratory rate
TV
Time frame: 10 minutes interval after the intubation during the surgery
Tidal volume
Compliance (Cdyn)
Time frame: 10 minutes interval after the intubation during the surgery
Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)
Resistance
Time frame: 10 minutes interval after the intubation during the surgery
Resistance (ventilator calculates: dividing the [peak pressure minus the plateau pressure] by the flowrate in litres per second)
3 secondary outcomes
HR
Time frame: 10 minutes interval after the intubation during the surgery
MP
Time frame: 10 minutes interval after the intubation during the surgery
SpO2
Time frame: 10 minutes interval after the intubation during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Vocal Cord Disease and Vocal Cord Cyst, run by Kocaeli University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIP (time frame: 10 minutes interval after the intubation during the surgery). The study lists 5 primary outcomes in all. 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 27 Feb 2026.