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临床试验/NCT06493162
NCT06493162已完成不适用

Comparison of Flow Controlled Ventilation and Volume Controlled Ventilation in Microscopic Laryngeal Surgeries, a Randomized Controlled Trial

Kocaeli University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

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

Active Comparator

Patients who will be ventilated with flow controlled ventilation following the intubation

干预措施: Intubation (Procedure)

FCV Group

Active Comparator

Patients who will be ventilated with flow controlled ventilation following the intubation

干预措施: Flow Controlled Ventilation (Device)

VCV Group

Active Comparator

Patients who will be ventilated with volume controlled ventilation following the intubation

干预措施: Volume Controlled Ventilation (Device)

VCV Group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hadi Ufuk Yörükoğlu

Principal investigator

Kocaeli University

研究点 (1)

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