跳至主要内容
临床试验/NCT06805357
NCT06805357招募中不适用

Evaluation of Lung Recruitment During Chest Physiotherapy in Mechanically Ventilated Patients

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Variation in FiO2 During the Session

研究概览

简要总结

In intensive care, respiratory physiotherapy is an integral part of the daily care of patients under invasive mechanical ventilation. Its goals are to improve the clearance of bronchial secretions to allow for the resolution of atelectasis and alveolar recruitment, thereby enhancing respiratory mechanics and gas exchange. The most widespread technique in France is external expiratory compression of the chest.

The effectiveness of this technique depends on the selection of patients (it seems to be more effective in patients with higher secretion levels) and on the practical implementation of the technique (favoring brief and vigorous compressions at the beginning of expiration). However, the effect of the artificial ventilator settings, particularly the ventilatory mode used during the respiratory physiotherapy session, has never been evaluated. The two most commonly used ventilatory modes worldwide are Volume Assist Control Ventilation (V-ACV) and pressure support ventilation (PSV). In this unit, respiratory physiotherapy under artificial ventilation is performed daily on patients with artificial ventilation with abundant secretions, regardless of the ventilatory mode.

详细描述

It is hypothesized that the effectiveness of respiratory physiotherapy on recruitment depends on the ventilatory mode used during the session.

The primary objective is to compare pulmonary recruitment during respiratory physiotherapy in patients under invasive mechanical ventilation between sessions performed in V-ACV and PSV.

Secondary objectives are to compare the effects of respiratory physiotherapy between V-ACV mode and PSV mode on respiratory mechanics, gas exchange, the amount of drained secretions (weight and volume), the distribution of ventilation, and patient tolerance.

Method:

A cross-over study with a non-invasive physiological endpoint. The primary evaluation criterion is variations in end-expiratory lung volume (ΔEELV) measured 5 minutes before and 5 minutes after a standardized respiratory physiotherapy session in V-ACV or PSV.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient under assisted ventilation (in V-ACV or PSV) triggering all ventilator cycles
  • •Patient deemed " secretive ": requiring ≥ 2 tracheal aspirations every 3 hours
  • •Patient (or relative) who has given consent to participate in the research
  • •Patient covered by social security

排除标准

  • •Age under 18 years
  • •Legal guardian required
  • •Recent cardiac and/or thoracic and/or abdominal surgery (< 3 months)
  • •Rib fracture(s)
  • •Pneumothorax and/or presence of a chest drain
  • •Recent neurosurgery (< 3 months) and/or proven or suspected increased intracranial pressure (ICP)
  • •Hemodynamic instability defined as: noradrenaline ≥ 1mg/h, adrenaline ≥ 0.5 mg/h, dobutamine ≥ 5γ/kg/min.
  • •Respiratory instability defined as: PEEP > 10 cmH2O and/or PaO2/FiO2 < 150 mm Hg
  • •Pregnancy
  • •Hemoptysis
  • •Sever skin lesions (e.g., burns, Lyell's syndrome)
  • •Patient under foreign health insurance

研究组 & 干预措施

RCC applied in V-ACV

Other

Doest't require description.

干预措施: Chest Physiotherapy by Rib Cage Compressions (RCC) (Other)

RCC applied in PS

Other

Doest't require description.

干预措施: Chest Physiotherapy by Rib Cage Compressions (RCC) (Other)

结局指标

主要结局

Variation in FiO2 During the Session

时间窗: FiO2 variation is during the physiotherapy session and up to 5 minutes after the session.

the variation in FiO2 (fraction of inspired oxygen) during the physiotherapy session. FiO2 refers to the percentage of oxygen delivered to the patient through the ventilator. This variation is tracked to assess any changes in the oxygen concentration during the session. The FiO2 variation is expressed as a percentage, with a typical variation of +10% during the procedure, measured using the CARESCAPE R860 ventilator.

Comparison of ΔEELV (after-before) Induced by an RCC Session Performed in V-ACV and PSV

时间窗: EELV is mesured 5 minutes before, 5 minutes after and 1 hour after each physiotherapy session (morning & afternoon).

the variation in end-expiratory lung volume (ΔEELV), which refers to the change in the volume of air in the lungs at the end of expiration. This is measured by comparing the end-expiratory lung volume 5 minutes before and 5 minutes after the respiratory physiotherapy session. The ΔEELV is measured in milliliters using the E-sCOVX module of the CARESCAPE R860 ventilator, which employs the nitrogen wash-in/wash-out technique.

次要结局

  • Measurement of Airflow in the Ventilator Circuit During Respiratory Physiotherapy Sessions(during and up to 5 minutes after each physiotherapy session)
  • mucus volume measurement(measured after each physiotherapy session.)
  • Assessment of gas exchange.(5 minutes before and 5 minutes after each physiotherapy session)
  • Assessment of regional lung ventilation distribution.(5 minutes before, during and 5 minutes after each physiotherapy session.)
  • Heart rate(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • Assessment of Airway Pressure Dynamics in the Ventilator Circuit During Respiratory Physiotherapy(during and up to 5 minutes after each physiotherapy session)
  • Quantification of mucus weight(measured after each physiotherapy session.)
  • Respiratory rate(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • oxygen saturation measurement(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • Blood pressure(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • end-tidal CO2 measurement(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • Tidal volume(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • minute volume(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • peak inspiratory pressure(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)
  • plateau pressure(5 minutes before, 5 minutes after and 1 hour after each physiotherapy session.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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