NCT07430124

Flow-Controlled Versus Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy

Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on airway pressures and oxygenation in adult patients undergoing balloon dilatation under direct laryngoscopy. Airway procedures performed under general anesthesia are associated with unique respiratory mechanics and limited ventilation conditions, making the choice of an optimal ventilation strategy particularly important. Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be allocated to receive either FCV or VCV during surgery. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points. The primary outcome is the PaO₂ measured 20 minutes under an FiO₂ of 0.8-1.0 after starting the ventilation under general anesthesia, reflecting early intraoperative oxygenation under stable conditions. By providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies in patients undergoing balloon dilatation under direct laryngoscopy.

Conditions

• Airway Stenosis
• Upper Airway Obstruction

Interventions

Type	Name	Description
PROCEDURE	FCV Group	Patients allocated to the FCV group will receive mechanical ventilation using a flow-controlled ventilation mode throughout the surgical procedure performed under general anesthesia. Ventilation will be managed according to routine clinical practice, with standardized anesthetic induction and monitoring. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group aims to evaluate the effects of FCV on airway pressures and early intraoperative oxygenation during balloon dilatation performed under direct laryngoscopy.
PROCEDURE	VCV Group	Patients allocated to the VCV group will receive mechanical ventilation using a conventional volume-controlled ventilation mode throughout the surgical procedure under general anesthesia. Anesthetic management and monitoring will follow standard clinical protocols identical to those applied in the FCV group. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas measurements will be recorded at the same predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group serves as the comparator arm to assess the effects of volume-controlled ventilation on airway pressures and oxygenation during balloon dilatation under direct laryngoscopy.

Timeline

• Start date: 2026-02-24
• Primary completion: 2026-08-07
• Completion: 2026-08-20
• First posted: 2026-02-24
• Last updated: 2026-02-25

Locations

1 site across 1 country: Turkey (Türkiye)