Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Compliance (Cdyn)
研究概览
简要总结
Flow-Controlled Ventilation is designed to ventilate the patient with constant flows during both inspiration and expiration. During inspiration, the pressure rises linearly from a set positive end-expiratory pressure (PEEP) to a set positive inspiratory pressure (PIP), and then falls linearly from PIP to end-expiratory pressure (EEP) during expiration. There are no flow interruptions during the Flow-Controlled Ventilation cycle, and the rate of change of pressure and volume in the lungs is equal, allowing for higher tidal volumes at lower pressures. The user sets the inspiratory flow rate and the ratio of inspiratory to expiratory time, providing full control over the ventilation cycle. However, this results in two unusual features: During inspiration, the ventilator creates positive pressure to direct gas into the patient's lungs through the endotracheal tube (ETT). When the intratracheal pressure (airway pressure) reaches the set PIP value, the ventilator switches from inspiration to expiration. By reversing the flow, it utilizes the Bernoulli effect to create negative pressure, facilitating expiration. Despite the presence of negative pressure on the ventilator side, the pressure in the patient's airway remains positive at all times.
Volume-controlled ventilation is a mode that is volume-controlled, time-cycled, time-triggered, and pressure-limited. In volume-controlled ventilation, high pressures are sometimes necessary to reach the target tidal volume. This can lead to barotrauma, atelectrauma, and volutrauma in the lungs. Therefore, to avoid high pressures, low tidal volume ventilation is preferred.
For Microscopic Laryngeal Surgeries, patients are intubated with a small sized endotracheal tube which results with higher pressures. We think that flow controlled ventilation will improve the ventilation during the surgery with lower pressures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo elective microscopic laser surgery
- •ASA status I and II
排除标准
- •Surgery time more than 2 hours
- •Patients with difficult intubation
- •Patients with chronic lung diseases
- •BMI > 25
研究组 & 干预措施
FCV Group
Patients who will be ventilated with flow controlled ventilation following the intubation
干预措施: Intubation (Procedure)
FCV Group
Patients who will be ventilated with flow controlled ventilation following the intubation
干预措施: Flow Controlled Ventilation (Device)
VCV Group
Patients who will be ventilated with volume controlled ventilation following the intubation
干预措施: Volume Controlled Ventilation (Device)
VCV Group
Patients who will be ventilated with volume controlled ventilation following the intubation
干预措施: Intubation (Procedure)
结局指标
主要结局
Compliance (Cdyn)
时间窗: 10 minutes interval after the intubation during the surgery
Dynamic compliance (ventilator calculates: Cdyn = tidal volume/(PIP - PEEP)
TV
时间窗: 10 minutes interval after the intubation during the surgery
Tidal volume
RR
时间窗: 10 minutes interval after the intubation during the surgery
Respiratory rate
PIP
时间窗: 10 minutes interval after the intubation during the surgery
Peak inspiratory pressure
Resistance
时间窗: 10 minutes interval after the intubation during the surgery
Resistance (ventilator calculates: dividing the \[peak pressure minus the plateau pressure\] by the flowrate in litres per second)
次要结局
- HR(10 minutes interval after the intubation during the surgery)
- MP(10 minutes interval after the intubation during the surgery)
- SpO2(10 minutes interval after the intubation during the surgery)
研究者
Hadi Ufuk Yörükoğlu
Principal investigator
Kocaeli University
