Flow-controlled versus volume-controlled breathing during balloon dilatation under direct laryngoscopy
Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07430124 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ankara
- Ankara Etlik City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.