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临床试验/NCT06293976
NCT06293976招募中不适用

Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume.

研究概览

简要总结

Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown.

Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT).

Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate [RR]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT.

详细描述

Participants. Critically ill patients (n: 30; aimed recruitment of equal numbers of men and women) aged 18 years or older admitted to the St. Michael's Hospital, Unity Health Toronto, Ontario, Canada.

Inclusion criteria:

  • patients intubated for more than 12 hours
  • exposed to sedation for at least 6 hours
  • with a sedation-agitation score ≤ 4
  • and corresponding to one of the following categories based on bedside inspection of ventilator waveforms:
  1. patients on assist-control ventilation having reverse triggering at clinical settings (n: 15).
  2. patients on assist-control ventilation without reverse triggering at the clinical settings (n: 15).

Exclusion criteria:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • primary severe neurological disorders
  • previous lung transplant
  • contraindications for esophageal catheter insertion
  • current use of continuous neuromuscular blocking agents at the time of the study procedure
  • severe metabolic acidosis (pH < 7.25) at the time of study procedure.

结局指标

主要结局

The rate of of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume.

时间窗: 1 minutes

The rate of reverse triggered breaths occurring after each change in the ventilator respiratory rate and tidal volume.

The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume

时间窗: 1 minute

The magnitude of the effort, measured by the drop in the esophageal pressure in cmH2O, associated with the reverse triggered breaths after each change in the ventilator respiratory rate and tidal volume

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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