An interventional study of FCV Group and VCV Group in Airway Stenosis and Upper Airway Obstruction, sponsored by Ankara Etlik City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Ankara Etlik City Hospital · Not applicable, Interventional, and Treatment
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.
154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.
This study's planned enrollment of 40 is below the median of 56 across 92 interventional studies indexed under Airway Obstruction.
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Exclusion Criteria:
Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. 80-100% FiO₂ will be applied, and a driving pressure of 12 cmH₂O will be used. After the 20th minute, the patient's FiO₂ will be adjusted according to the clinical condition. Tidal volume will be generated and recorded by the ventilator according to the driving pressure and the patient's lung mechanics. Minute ventilation will be adjusted based on the target tidal volume. The target tidal volume will be set at 6-8 mL/kg (7 mL/kg) with a respiratory rate of 12 breaths/min. Positive end-expiratory pressure (PEEP) will be maintained at 5 cmH₂O. The respiratory rate was further titrated to maintain ETCO₂ between 35 and 40 mmHg.
Procedure: FCV Group
Patients allocated to the VCV group will receive intraoperative mechanical ventilation using a conventional volume-controlled ventilation mode throughout surgery under general anesthesia. Patients will be started on ventilation after intubation with 80-100% FiO₂, 7 ml/ideal body weight tidal volume, PEEP 5, 12 breaths per minute frequency, and a 1:2 inspiration/expiration ratio. After the 20th minute, the patient's FiO₂ will be adjusted according to the clinical condition.
Procedure: VCV 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.
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.
The PaO₂ measured 20 minutes after intubation.
The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after intubation.
Time frame: 20 minutes after intubation in the intraoperative period
The PaO₂ measured during perioperative period
The PaO₂ values will be measured and recorded using arterial blood gas analysis.
Time frame: At the initiation of mechanical ventilation following intubation and at the first postoperative hour after extubation
Peak airway pressure (Ppeak) values during perioperative period.
Ppeak will be measured and recorded.
Time frame: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation
Plateau airway pressure (Pplateau) values during perioperative period
Pplateau will be measured and recorded.
Time frame: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation
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Ankara Etlik City Hospital