Flow-controlled versus volume-controlled breathing during balloon dilatation under direct laryngoscopy
Official title: Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial
Run by Ankara Etlik City Hospital · NCT07430124 · Data updated 2026-11-12
This trial tests whether flow-controlled or volume-controlled ventilation gives better oxygen levels and airway pressures in adults (18–65 years) having balloon dilatation under direct laryngoscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | February 24, 2026 |
| Main results expected | August 7, 2026 |
| Study ends | August 20, 2026 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT07430124 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with ASA physical status I–III undergoing balloon dilatation under direct laryngoscopy who do not have significant preexisting lung disease are the ideal candidates.
✕Probably not a fit
Patients with known or severe pulmonary disease, those dependent on supplemental oxygen, patients with major prior thoracic surgery, ASA IV or higher, or those outside the 18–65 age range are unlikely to benefit from the trial's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective interventional comparison in which adult patients 18–65 years with ASA physical status I–III will be allocated to receive either flow-controlled ventilation (FCV) or volume-controlled ventilation (VCV) during balloon dilatation under general anesthesia. Intraoperative ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined time points. The primary outcome is arterial PaO₂ measured 20 minutes after starting ventilation while receiving an FiO₂ of 0.8–1.0 to capture early intraoperative oxygenation under stable conditions. Patients with known significant pulmonary disease, severe preoperative pulmonary impairment, dependency on supplemental oxygen, major prior thoracic surgery, ASA IV or higher, or inability to consent will be excluded.
Why it matters
Potential benefit: If successful, the preferred ventilation mode could improve intraoperative oxygenation and reduce airway pressures during laryngeal balloon dilatation.
How similar studies have gone: Some physiological studies and small clinical reports suggest FCV can lower airway pressures and improve compliance compared with conventional modes, but randomized data in this specific laryngoscopic balloon dilatation setting are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years * ASA physical status I-III Exclusion Criteria: * Age \< 18 years or \> 65 years * Known or previously diagnosed pulmonary disease * Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ \< 50% predicted, severe restrictive or obstructive pathology) * Patients with markedly altered lung anatomy or function due to prior major thoracic surgery * Patients who were dependent on supplemental oxygen therapy in the preoperative period * ASA physical status IV or higher * Refusal or inability to provide informed consent
Where it's running
-
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye) Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ketamine and optic nerve swelling during procedural pain relief
This study tests whether giving ketamine for procedural pain relief changes the optic nerve sheath diameter in adults, using bedside ultrasound before and after dosing to see if intracranial pressure shifts differ by ketamine dose.
-
Analgesic effects of adding BiFeS block to adductor canal block after ACL reconstruction
This study tests whether adding a BiFeS block to the standard adductor canal block provides better pain relief after ACL reconstruction.
-
Surface topography and spine damage in radiographic axial spondyloarthritis
This study tests whether a radiation-free 3D surface topography method can reflect spine damage and sagittal balance in adults with radiographic axial spondyloarthritis.
-
Theta Burst Stimulation to Help Stroke Recovery (Upper and Lower Limbs)
This trial tests whether applying theta burst stimulation to the motor cortex, in combination with standard rehabilitation, helps people over 45 who recently had a first ischemic stroke recover arm and leg movement.
-
GNRI and PNI to predict short-term outcomes in older adults with multiple rib fractures
This study tests whether GNRI and PNI, calculated from routine data, can help predict short-term outcomes for adults 65 and older with several rib fractures after blunt chest trauma.
-
Perfusion index in the emergency department to gauge DKA severity
This study tests whether the perfusion index measured at ED admission can help predict how severe diabetic ketoacidosis will be in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.