Titration of Positive End-expiratory Pressure: Comparison Between Manual Thoracic or Abdominal Compression and Electrical Impedance Tomography (TICTAC)
2026年5月29日 更新者：Centre Hospitalier Saint Joseph Saint Luc de Lyon
Patients with acute respiratory distress syndrome are placed on mechanical ventilation, and the adjustment of ventilator parameters is an important step in their care, in particular positive expiratory pressure, applied at the end of breathing.
The goal of this study is to learn if continuous anterior chest compression works as well as electrical impedance tomography for positive expiratory pressure titration.
Researchers will compare the two methods for each patient, in a randomly determined order : continuous anterior chest compression and electrical impedance tomography.
Participants will :
- have a pep titration with both techniques
- be included in the study for 28 days
研究概览
详细说明
Personalizing the PEEP level is an important step in ventilator adjustment in ARDS patients.
The investigators have developed a simple, low-cost method to detect overdistension of the lung, consisting of applying manual compression to the anterior aspect of the patient's thorax, and observing whether the ventilator pressure increases or decreases.
The investigators hypothesize that with this simple method it is possible to determine the PEEP level which corresponds to that determined with EIT.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Emmanuel Vivier, MD
- 电话号码：+33(0)478618209
- 邮箱：evivier@saintjosephsaintluc.fr
研究联系人备份
- 姓名：Fanny Doroszewski, Mrs
- 电话号码：+33(0)47861820 +33(0)478618398
- 邮箱：fdoroszewski@saintjosephsaintluc.fr
学习地点
-
-
-
Créteil、法国、94000
- 招聘中
- GHU Henri Mondor
-
接触：
- Guillaume Carteaux, Pr
- 电话号码：+33149812111
- 邮箱：guillaume.carteaux@aphp.fr
-
首席研究员：
- Guillaume Carteaux, Pr
-
副研究员：
- Pascal Labedade, Dr
-
Lyon、法国、69007
- 招聘中
- Hôpital Saint Joseph Saint Luc
-
首席研究员：
- Emmanuel Vivier, Dr
-
接触：
- Emmanuel Vivier, Dr
- 电话号码：+33478618209
- 邮箱：evivier@saintjosephsaintluc.fr
-
接触：
- Fanny Doroszewski
- 电话号码：+33478618398
- 邮箱：fdoroszewski@saintjosephsaintluc.fr
-
副研究员：
- Samuel Tuffet, Dr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years
- Moderate to severe ARDS according to the Berlin criteria
- Patient receiving sedation and continuous curarization
- Free and informed consent from the patient or their loved one
Exclusion Criteria:
- ECMO
- Pneumothorax
- Chest trauma in the last 3 months
- Uncontrolled shock (noradrenaline > 5 mg/h)
- Pregnant or breastfeeding woman
- Protected adult within the meaning of the law
- Lack of social security
- Patient under AME
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：PEEP 滴定
|
Assessment of ideal PEEP using electrical impedance tomography will be performed.
The evaluation of PEEP using the thorax compression maneuver method will be carried out.
A blood sample (the "blood gases") will be taken at the ideal PEEP determined by electrical impedance tomography and at the ideal PEEP determined by the manual chest compression maneuver.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PEPCTAC
大体时间：Day 0
|
PEPCTAC (unit : cmH2O)
|
Day 0
|
|
PEPCAC
大体时间：Day 0
|
PEPCAC (unit : cmH2O)
|
Day 0
|
|
PEPEIT
大体时间：Day 0
|
PEPEIT (unit : cmH2O)
|
Day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of collapse at PEPCTAC
大体时间：Day 0
|
Percentage of collapse at PEPCTAC
|
Day 0
|
|
Percentage of collapse at PEPCAC
大体时间：Day 0
|
Percentage of collapse PEPCAC
|
Day 0
|
|
Percentage of collapse at PEPEIT
大体时间：Day 0
|
Percentage of collapse at PEPEIT
|
Day 0
|
|
Compare respiratory mechanics for PEPCTAC and PEPCAC and PEPEIT
大体时间：Day 0
|
Respiratory mechanics at PEPCTAC and PEPCAC ans PEPEIT : peak and plateau pressure, driving pressure, respiratory system compliance, pulmonary and parietal compliance, respiratory system resistance, end-expiratory transpulmonary pressure, stress index at each PEEP level
|
Day 0
|
|
Compare PEPCTAC and other PEEP adjustment methods reported in the literature
大体时间：Day 0
|
Comparison of the PEPCTAC level to the PEP level according to the maximum recruitment arm of the Express study (PEP level which is accompanied by a Pplat between 28 and 30 cm H2O), Comparison of the PEPCTAC level to the PEP level according to the PEP/FiO2 scales, Comparison of the PEPCTAC level to the minimum PEEP level to obtain a positive end-expiratory transpulmonary pressure
|
Day 0
|
|
Evaluate the effect of CTAC on plateau pressure based on levels of distension and collapse resulting from PEEP
大体时间：Day 0
|
• Correlation between variation of plateau pressure with CTAC and percentage of distension linked to PEEP
|
Day 0
|
|
Evaluate the effect of CTAC on plateau pressure based on levels of collapse resulting from PEEP
大体时间：Day 0
|
• Correlation between variation of plateau pressure with CTAC and percentage of collapsus linked to PEEP
|
Day 0
|
|
Evaluate the effect of CTAC on plateau pressure based on the distribution of ventilation between dependent and non-dependent zones resulting from PEEP
大体时间：Day 0
|
Correlation between variation of plateau pressure with CTAC and percentage of anterior ventilation
|
Day 0
|
|
Evaluate the effects of CTAC on regional compliance according to the level of PEP
大体时间：Day 0
|
Regional compliances (four areas of interest with antero-posterior distribution) of the respiratory and pulmonary system estimated using EIT, airway pressure and esophageal pressure
|
Day 0
|
|
Evaluate the effect of recruitability potential on the level of PEPCTAC and PEPEIT
大体时间：Day 0
|
R/I ratio
|
Day 0
|
|
Evaluate the effect of airway opening pressure on the level of PEPCTAC and PEPEIT
大体时间：Day 0
|
Evaluation of the airway opening pressure by performing a slow flow pressure-volume curve (quasi-static condition) from a PEEP set at zero cm H2O
|
Day 0
|
|
Evaluate the effects of PEEP on right ventricular function
大体时间：Day 0
|
Right ventricular function assessed by echocardiography: mitral inflow, subaortic VTI, subpulmonary VTI, continuous-wave pulmonary Doppler and assessment of pulmonary regurgitation, continuous Doppler, TAPSE (tricuspid annular plane systolic excursion), tricuspid annular S-wave.
Presence of acute cor pulmonale defined by an RV/LV ratio > 0.6 associated with paradoxical septal motion, PAPi (pulmonary artery pulsatility index).
Septal and free-wall right ventricular strains.
|
Day 0
|
|
Evaluate the effect of PEEP on venous congestion
大体时间：Day 0
|
Venous congestion assessed by ultrasound (VExUS score)
|
Day 0
|
|
Compare the percentages of distension between PEPCTAC and PEPCAC and PEPEIT
大体时间：Day 0
|
Percentages of distension between PEPCTAC and PEPCAC and PEPEIT
|
Day 0
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月7日
初级完成 (估计的)
2027年5月5日
研究完成 (估计的)
2027年5月5日
研究注册日期
首次提交
2024年11月19日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.