Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The PaO₂ measured 20 minutes after intubation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •ASA physical status I-III
排除标准
- •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
研究组 & 干预措施
FCV Group
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.
干预措施: FCV Group (Procedure)
VCV 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.
干预措施: VCV Group (Procedure)
结局指标
主要结局
The PaO₂ measured 20 minutes after intubation.
时间窗: 20 minutes after intubation in the intraoperative period
The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after intubation.
次要结局
- The PaO₂ measured during perioperative period(At the initiation of mechanical ventilation following intubation and at the first postoperative hour after extubation)
- Peak airway pressure (Ppeak) values during perioperative period.(At the initiation of mechanical ventilation following intubation and 20 minutes after intubation)
- Plateau airway pressure (Pplateau) values during perioperative period(At the initiation of mechanical ventilation following intubation and 20 minutes after intubation)
研究者
Atakan Sezgi
Principal Investigator
Ankara Etlik City Hospital