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临床试验/NCT07796321
NCT07796321尚未招募不适用

Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Average effort of breathing

研究概览

简要总结

The goal of this trial is to learn if one mode of mechanical ventilation (i.e. machine to help with breathing) is better than another in children who need help from a machine to breathe. The main questions it aims to answer are:

  • How hard do children need to work to breathe when they are using different types of modes of mechanical ventilation?
  • Evaluate which mode of mechanical ventilation performs better when the patient is clinically awake enough to start breaths

详细描述

Single centre, randomized crossover physiological study to assess effort of breathing and dyssynchrony burden associated with different modes of assisted ventilation in children. We hypothesize that patients on optimized pressure support ventilation (PSV) will 1) not have higher effort of breathing and 2) have a reduced rate of dyssynchronous effort compared to pressure control ventilation (PCV) or synchronized intermittent mandatory ventilation pressure control/pressure support (SIMV PC/PS) that is the current standard of care.

An esophageal catheter will be inserted and calibrated for measuring esophageal pressure (Pes) swings to quantify breathing effort and diagnose dyssynchronies. During passive breathing, the chest wall compliance will be measured. When the patients are in the ventilation weaning phase and triggering consistently in SIMV mode, a 30 min recording of respiratory signals will be performed (clinical mode) followed by exposure to two modes of assisted ventilation (PCV or PSV) in a randomized crossover manner for 30 min each. Level of support (the pressure above the PEEP) and sedation will remain stable within each participant. PSV optimization: If the PS breath is too short (< 0.2 sec), the inspiratory rise time will be increased to 0.15 sec and the cycling % reduced to 20, 15 or 10% to ensure an adequate size breath (approx 1/3 of the patient's respiratory cycle).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Consent provided
  • Aged: birth to 18 years of age
  • Invasively mechanically ventilated and expected to remain intubated for ≥ 6 hours, in the ventilator weaning phase.

排除标准

  • Contraindication for esophageal catheter placement such as esophageal repair (e.g. esophageal surgery or esophageal varices)
  • On Extracorporeal Membrane Oxygenation (ECMO)
  • Undergoing assessment for brain death or brain death confirmed
  • Patients with a severe systemic disease that poses a constant threat to their life:
  • <24 hrs post cardiac arrest
  • 2 or more inotropes increasing by >20% within the last 24 hrs
  • increase in ventilation support or an FiO2 change ≥30% within the last 24 hrs
  • most responsible physician (MRP) determine patient is not eligible for the study intervention

研究组 & 干预措施

PCV followed by PSV

Experimental

SIMV PC/PS (30 mins) followed by PCV (30 mins) followed by PSV (30 mins)

干预措施: Pressure Control Mode (Device)

PCV followed by PSV

Experimental

SIMV PC/PS (30 mins) followed by PCV (30 mins) followed by PSV (30 mins)

干预措施: Pressure Support Mode (Device)

PSV followed by PCV

Experimental

SIMV PC/PS (30 mins) followed by PSV (30 mins) followed by PCV (30 mins)

干预措施: Pressure Control Mode (Device)

PSV followed by PCV

Experimental

SIMV PC/PS (30 mins) followed by PSV (30 mins) followed by PCV (30 mins)

干预措施: Pressure Support Mode (Device)

结局指标

主要结局

Average effort of breathing

时间窗: Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).

Muscular pressure or Pmus (calculated from DPes and using the chest wall compliance of the participant and measured by specific software \[FluxReview\]) during the assisted modes. For each patient, the change in Pmus from SIMV to PSV and from SIMV to PCV will be computed. The within-patient difference between these changes will be summarized in terms of median and interquartile range, and assessed using a Wilcoxon signed-rank test.

次要结局

  • Dyssynchrony rate quantified by specific software (FluxReview)(Approximately 90 minutes (30 minutes per mode of mechanical ventilation))

研究者

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

Luciana Rodriguez Guerineau

Staff Physician

The Hospital for Sick Children

研究点 (1)

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