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临床试验/NCT07319624
NCT07319624已完成不适用

Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children

Papa Giovanni XXIII Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Feasibility (% of patients that complete the EIT-guided PEEP trial)

研究概览

简要总结

This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age. This population is challenging for its variety and anatomophysiologic peculiarity. A decremental PEEP trial using 1 cmH₂O steps following a recruitment maneuver at 35 cmH₂O was compared between EIT and other best PEEP assessment protocols.

详细描述

The study enrolled consecutive patients under 3 years of age who required mechanical ventilation due to impaired oxygenation or altered respiratory mechanics. Impaired oxygenation sufficient for inclusion was defined as an oxygenation index (OI) greater than 4, defined as mean airway pressure multiplied by FiO₂ divided by PaO₂, and/or an oxygen saturation index (OSI), defined as mean airway pressure multiplied by FiO₂ divided by SpO₂, greater than 5. Altered respiratory mechanics sufficient for inclusion was defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.

Patients were excluded if they had contraindications to the placement of the EIT belt, such as thoracic fractures, chest drains, or subcutaneous thoracic devices. The presence of intracardiac shunts was also an exclusion criterion. Further exclusions included confirmed or suspected pneumothorax on chest X-ray or lung ultrasound, hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers. Technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability, belt-to-chest size incompatibility (< 3 kg), or the need for urgent clinical interventions, also led to exclusion. Lack of informed consent from parents or legal guardians precluded enrollment.

Study Protocol The stepwise PEEP titration protocol used in this study is partially part of a clinical approach routinely adopted in the PICU of our institution to optimize lung recruitment and individualize ventilator settings in mechanically ventilated children.

According this study protocol, once clinical stabilization was achieved - defined as adequate sedation and analgesia, cardiovascular stability, and appropriate patient-ventilator synchrony -neuromuscular blockade was administered. An EIT belt with 16 electrodes (PulmoVista® 500, Dräger Medical GmbH, Lübeck, Germany) appropriate to the patient's weight was placed at the fourth or fifth intercostal space along the axillary line.

Baseline parameters were collected, including gas exchange data, respiratory mechanics, and ventilator settings (PEEP, tidal volume [Vt], respiratory rate, driving pressure [ΔP], compliance [Crs], FiO₂, SpO₂, OI or OSI), as well as blood gas analysis when available. PEEP was initially set according to the ARDSNet lower PEEP/higher FiO₂ table, referred to as PEEPnih. If children was volume-controlled ventilate, pressure-controlled ventilation was applied with an inspiratory pressure above PEEP equal to the baseline ΔP to maintain a similar Vt regardless of the previous ventilation mode.

研究设计

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

入排标准

年龄范围
0 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age under 3
  • Impaired oxygenation - defined as an
  • oxygenation Index (OI = mean airway pressure multiplied by FiO₂ divided by PaO₂) greater than 4; and/or
  • an Oxygen Saturation Index (OSI = mean airway pressure multiplied by FiO₂ divided by SpO₂) greater than 5; or
  • altered respiratory mechanics - defined as reduced respiratory system compliance normalized to body weight (Crs/kg) below 0.7 mL/cmH₂O/kg.

排除标准

  • thoracic fractures
  • chest drains
  • subcutaneous thoracic devices
  • presence of intracardiac shunts
  • confirmed or suspected pneumothorax on chest X-ray or lung ultrasound
  • hemodynamic instability requiring adrenaline or noradrenaline at doses exceeding 0.05 mcg/kg/min, or a reduction in systolic blood pressure greater than 30% during recruitment maneuvers.
  • technical issues that prevented reliable acquisition of EIT signals, including prolonged signal instability
  • belt-to-chest size incompatibility (< 3 kg)
  • lack of informed consent

结局指标

主要结局

Feasibility (% of patients that complete the EIT-guided PEEP trial)

时间窗: 20 weeks

assessing the feasibility of an individualized PEEP titration using an EIT-guided decremental PEEP trial specifically designed for smaller children.

次要结局

  • To compare PEEPeit (cmH2O) with PEEPnih (cmH2O)(20 weeks)
  • To evaluate changes of EIT patterns of overdistension (%) and derecruitment (%) according to changes in respiratory system Compliance-guided method (mL/cmH2O)(20 weeks)
  • To assess changes in respiratory system compliance (mL/cmH2O) across different PEEP levels (cmH2O)(20 weeks)
  • To assess changes in end-expiratory lung impedance (arbitrary units) by EIT across different PEEP levels (cmH2O)(20 weeks)
  • To assess changes in oxygenation (PaO2/FiO2, mmHg) across different PEEP levels(20 weeks)

研究者

发起方
Papa Giovanni XXIII Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfio Bronco

Principal Investigator - Consultant Pediatric Intensivist

Papa Giovanni XXIII Hospital

研究点 (1)

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