Laryngeal DiseasesNCT07639398
Flow-Controlled Versus Volume-Controlled Ventilation During Suspension Laryngoscopy
An observational study of Laryngeal Diseases and Airway Management, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Suspension laryngoscopy presents significant challenges for airway management due to the need to maintain adequate ventilation while providing optimal surgical exposure. Flow-controlled ventilation (FCV) is a novel ventilation mode that delivers constant inspiratory and expiratory flow using a narrow-lumen, cuffed… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngeal Diseases, Airway Management
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 19 Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 65 years scheduled for elective suspension laryngoscopy under general anesthesia were included. Eligible participants had an American Society of Anesthesiologists (ASA) physical status of I-III and a body mass index between 18 and 40 kg/m². All participants provided written informed consent prior to participation.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective suspension laryngoscopy under general anesthesia
- Body mass index between 18 and 40 kg/m²
- Provision of written informed consent
- Exclusion Criteria:- Severe cardiac, pulmonary, hepatic, or renal disease
- Inability to cooperate with pulmonary function testing
- Intraoperative hemodynamic instability or oxygen desaturation (SpO₂ <92%)
- Requirement for tracheostomy during the procedure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Ankara, 06530
About this study
Official title: Comparison of Flow-Controlled Ventilation and Volume-Controlled Ventilation on Respiratory Mechanics During Suspension Laryngoscopy: A Prospective Observational Study
Suspension laryngoscopy presents significant challenges for airway management due to the need to maintain adequate ventilation while providing optimal surgical exposure. Flow-controlled ventilation (FCV) is a novel ventilation mode that delivers constant inspiratory and expiratory flow using a narrow-lumen, cuffed endotracheal tube, potentially improving ventilation efficiency in shared-airway surgeries.
This prospective observational study aims to compare flow-controlled ventilation and conventional volume-controlled ventilation in patients undergoing elective suspension laryngoscopy. Respiratory mechanics, hemodynamic parameters, perioperative pulmonary function, and procedure-related complications will be evaluated to assess the feasibility and clinical performance of FCV in this surgical setting.
Read the detailed description
Suspension laryngoscopy is a shared-airway surgical procedure that requires optimal visualization of the operative field while maintaining adequate ventilation and oxygenation. Conventional ventilation strategies may be associated with increased airway pressures and limited surgical exposure due to the use of standard endotracheal tubes. Flow-controlled ventilation (FCV) is a ventilation mode characterized by constant inspiratory and expiratory flow, which may offer advantages in procedures requiring a narrow airway device.
This prospective, non-randomized, observational comparative study evaluates adult patients undergoing elective suspension laryngoscopy. The choice of ventilation strategy-flow-controlled ventilation or conventional volume-controlled ventilation-was based on the attending anesthesiologist's clinical preference, reflecting routine clinical practice. All patients provided written informed consent prior to participation.
In both groups, standardized anesthetic management was applied, and ventilation parameters were adjusted to maintain normocapnia and adequate oxygenation. Intraoperative respiratory mechanics, including airway pressures and lung compliance, were recorded at predefined intervals. Hemodynamic parameters were monitored throughout the procedure. Pulmonary function tests were performed preoperatively and postoperatively using a portable spirometry device. Perioperative complications were documented.
The primary objective of this study is to compare intraoperative respiratory mechanics between flow-controlled and volume-controlled ventilation during suspension laryngoscopy. Secondary objectives include the assessment of perioperative hemodynamic parameters, changes in pulmonary function, and procedure-related complications.
- Conditions
- Laryngeal Diseases, Airway Management
- Keywords
- Flow Controlled Ventilation, Volume Controlled Ventilation, Suspension Laryngoscopy, Airway Manegement, Respiratory Mechanics
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Flow-Controlled Ventilation Group | Patients undergoing elective suspension laryngoscopy who were ventilated using flow-controlled ventilation based on the attending anesthesiologist's clinical preference. | |
| Volume-Controlled Ventilation Group | Patients undergoing elective suspension laryngoscopy who were ventilated using conventional volume-controlled ventilation based on the attending anesthesiologist's clinical preference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
Intraoperative peak airway pressure (cmH2O) measured at predefined time intervals during suspension laryngoscopy.
Measured: During surgery with 10 minute intervals
Secondary outcomes (5)
Respiratory system compliance
Respiratory system compliance (mL/cmH2O) measured at predefined intraoperative time intervals.
Measured: Intraoperative period during suspension laryngoscopy with 10 minute intervals.
End tidal carbondioxide
End-tidal carbon dioxide levels (mmHg) measured during suspension laryngoscopy.
Measured: Intraoperative period during suspension laryngoscopy with 10 minute intervals
Peripheral oxygen saturation
Peripheral oxygen saturation (%) measured during suspension laryngoscopy.
Measured: Intraoperative period during suspension laryngoscopy with 10 minute intervals.
Forced expiratory volume in one second
Preoperative and postoperative forced expiratory volume in one second (liter) measured using pulmonary function testing.
Measured: 30 minutes before surgery and 12 hours after surgery
Forced vital capacity
Preoperative and postoperative forced vital capacity (liter) measured using pulmonary function testing.
Measured: 30 minutes before surgery and 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start20 Dec 2023
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DiseasesStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Birkan Arı, Ankara Training and Research Hospital
- Investigators
- Salih Birkan ARI, M.D., Principal investigator, Ankara Trainig and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639398
- Sponsor's protocol ID
- 1490/2023
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual participant data, as the study is an academic, single-center observational study and only aggregate data will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 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 on Respiratory Mechanics During Suspension Laryngoscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07639398
- Acronym / sponsor ID
- 1490/2023
- Conditions
- Laryngeal Diseases, Airway Management
- Keywords
- Flow Controlled Ventilation, Volume Controlled Ventilation, Suspension Laryngoscopy, Airway Manegement, Respiratory Mechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 10 Jun 2026 (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.
Suspension laryngoscopy presents significant challenges for airway management due to the need to maintain adequate ventilation while providing optimal surgical exposure. Flow-controlled ventilation (FCV) is a novel ventilation mode that delivers constant inspiratory and expiratory flow using a narrow-lumen, cuffed endotracheal tube, potentially improving ventilation efficiency in shared-airway surgeries.
This prospective observational study aims to compare flow-controlled ventilation and conventional volume-controlled ventilation in patients undergoing elective suspension laryngoscopy. Respiratory mechanics, hemodynamic parameters, perioperative pulmonary function, and procedure-related complications will be evaluated to assess the feasibility and clinical performance of FCV in this surgical setting.
Detailed description
Suspension laryngoscopy is a shared-airway surgical procedure that requires optimal visualization of the operative field while maintaining adequate ventilation and oxygenation. Conventional ventilation strategies may be associated with increased airway pressures and limited surgical exposure due to the use of standard endotracheal tubes. Flow-controlled ventilation (FCV) is a ventilation mode characterized by constant inspiratory and expiratory flow, which may offer advantages in procedures requiring a narrow airway device.
This prospective, non-randomized, observational comparative study evaluates adult patients undergoing elective suspension laryngoscopy. The choice of ventilation strategy-flow-controlled ventilation or conventional volume-controlled ventilation-was based on the attending anesthesiologist's clinical preference, reflecting routine clinical practice. All patients provided written informed consent prior to participation.
In both groups, standardized anesthetic management was applied, and ventilation parameters were adjusted to maintain normocapnia and adequate oxygenation. Intraoperative respiratory mechanics, including airway pressures and lung compliance, were recorded at predefined intervals. Hemodynamic parameters were monitored throughout the procedure. Pulmonary function tests were performed preoperatively and postoperatively using a portable spirometry device. Perioperative complications were documented.
The primary objective of this study is to compare intraoperative respiratory mechanics between flow-controlled and volume-controlled ventilation during suspension laryngoscopy. Secondary objectives include the assessment of perioperative hemodynamic parameters, changes in pulmonary function, and procedure-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow-Controlled Ventilation Group | – | –Patients undergoing elective suspension laryngoscopy who were ventilated using flow-controlled ventilation based on the attending anesthesiologist's clinical preference. |
| Volume-Controlled Ventilation Group | – | –Patients undergoing elective suspension laryngoscopy who were ventilated using conventional volume-controlled ventilation based on the attending anesthesiologist's clinical preference. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 65 years scheduled for elective suspension laryngoscopy under general anesthesia were included. Eligible participants had an American Society of Anesthesiologists (ASA) physical status of I-III and a body mass index between 18 and 40 kg/m². All participants provided written informed consent prior to participation.
Key inclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective suspension laryngoscopy under general anesthesia
- Body mass index between 18 and 40 kg/m²
- Provision of written informed consent
- Exclusion Criteria:- Severe cardiac, pulmonary, hepatic, or renal disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak airway pressure
Time frame: During surgery with 10 minute intervals
Intraoperative peak airway pressure (cmH2O) measured at predefined time intervals during suspension laryngoscopy.
5 secondary outcomes
Respiratory system compliance
Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals.
End tidal carbondioxide
Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals
Peripheral oxygen saturation
Time frame: Intraoperative period during suspension laryngoscopy with 10 minute intervals.
Forced expiratory volume in one second
Time frame: 30 minutes before surgery and 12 hours after surgery
Forced vital capacity
Time frame: 30 minutes before surgery and 12 hours after 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 10 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data, as the study is an academic, single-center observational study and only aggregate data will be reported.
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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.
Salih Birkan ARI, M.D. principal investigator
Ankara Trainig and Research 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 Laryngeal Diseases and Airway Management, run by Ankara 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 8 inclusion and 0 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 10 Jun 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?
Peak airway pressure (time frame: During surgery with 10 minute intervals). 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 10 Jun 2026.