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临床试验/NCT05876468
NCT05876468招募中不适用

" Effects of Continuous Anterior Chest Compression (CACC) & Comparision With Prone Position in ARDS Patients " The StrapVent Study "

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月1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
20
试验地点
2
主要终点
The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water

研究概览

简要总结

The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.

详细描述

Acute respiratory distress syndrome (ARDS) is usually characterized by inhomogeneous lesions, leading to an inhomogeneous distribution of the mechanical ventilation with the following several deleterious effects: atelectrauma of dependent posterior areas and overdistension in the anterior ones. Therefore, the gold standard treatment is to prevent VILI with lung protective ventilation : low tidal volume, high positive end expiratory pressure and prone positioning which is a technique that reduces mortality. Prone positioning has several beneficial effects : it relieves cardiac compression of the supporting lung, it stiffens the anterior chest wall thus limiting the risk of overdistension of anterior areas and promotes recruitment of non-dependent posterior pulmonary units. The overall effect is a more uniform distribution of transpulmonary pressures and improved ventilation to perfusion ratios.

Similar to prone positioning, continuous anterior chest wall compression stiffens the anterior chest wall. The investigators hypothesize that such reduction in anterior chest wall compliance may protect against overdistension and promote the redistribution of the ventilation in posterior areas.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Age ≥ 18 ans
  • Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio <= 200 mmHg)
  • The patent must be sedated and paralyzed
  • Informed consent from patient or family members

排除标准

  • Extracorporeal membrane oxygenation (ECMO)
  • Pneumothorax
  • Thoracic trauma during the last 3 months
  • Refractory shock
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Pregnancy
  • Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
  • No social care
  • Adults under Guardianship, curatorship or protection of the court

结局指标

主要结局

The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water

时间窗: Through study completion (up to 6 hours)

The transpulmonary pressure will be measured by using an esophageal catheter connected to a differential pressure transducer. The PL-insp will be calculated using the ratio between the elastance of the lung (El) and of the respiratory system (Ers) expressed in centimetre of water thanks to this formula PL-insp = Plateau pressure x (El/Ers). The PL-insp between the different protocol conditions will be compared (After 16 hours of prone position, in supine position, 15mn after CACC with a pressure equal to the one observed in the prone position, 15mn after CACC with a pressure set at 60 - 80 cmH20, 15mn after taking off the CACC in supine position ). CACC will be considered protective if there is a decrease in Pl-insp.

次要结局

  • Lung mechanics : Airways pressure, Flow curves and Esophageal pressure(Through study completion (up to 6 hours))
  • Regional pulmonary compliances in centimetre of water(Through study completion (up to 6 hours))
  • Recruitment-to-inflation (R/I) ratio(Through study completion (up to 6 hours))
  • Incidence of CACC adverse events(Through study completion (up to 6 hours))
  • End expiratory lung impedance (EELZ) expressed in arbitrary units(Through study completion (up to 6 hours) ])
  • Pulmonary ventilation distribution in percentage(Through study completion (up to 6 hours))
  • Arterial blood gazes (ABG(Through study completion (up to 6 hours))
  • Hemodynamics(Through study completion (up to 6 hours))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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