跳至主要内容
临床试验/NCT03511651
NCT03511651Unknown不适用

The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation

Capital Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
The change of FRC

研究概览

简要总结

Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at different PEEP levels remains unknown.

详细描述

Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP.

Passive spirometry has long been used to measure the lung recruitment volume (VREC). A prolonged expiration to zero end-expiratory pressure (ZEEP) or airway release maneuver is required and PEEP induced lung volume change above functional residual capacity (FRC) is measured. This technique assumes that FRC does not change at different PEEP levels.

This assumption that PEEP has no effect on FRC can date back to the study of Valta et al in the early 1990s. Using respiratory inductive plethysmography (RIP), they found that in ALI/ARDS patients, after expiring from different PEEP levels to ZEEP, the plethysmography signal returned to the same baseline value. They concluded that FRC does not change with PEEP, and that changes of EELV are attributable only to change in ∆EELV. Ranieri et al arrived at similar conclusions by measuring differences in lung volumes at different PEEP levels using standardized pressure-volume (P-V) curves derived from the ventilator circuit monitors. However, Patroniti et al found an elevation of FRC as increasing of PEEP in patients with ARDS. In this study, FRC was measured with the helium dilution technique, and concluded that neglecting this effect resulted in marked underestimation of VREC. Whether the FRC changes at different PEEP levels remains controversial. The aim of the study is to assess the effect of PEEP on FRC during mechanical ventilation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with ARDS according to the Berlin Definition;
  • Age 18-80 years;
  • Ventilated with volume-controlled ventilation using constant flow;
  • Deep sedation (RASS -4 to -5) and absence of spontaneous breathing (i.e., no triggering during tidal breaths and no inspiratory effort during a 5-second end-expiratory hold).

排除标准

  • Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
  • Chest wall and/or abdominal injuries;
  • Evidence suggesting reduced chest wall compliance, such as existing large pleural effusion, thoracic trauma and intra-abdominal hypertension (i.e., intra-abdominal pressure > 20 mmHg).
  • Presence of pacemaker, defibrillator, and implantable pumps).

结局指标

主要结局

The change of FRC

时间窗: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O

EELV measurement by ICU ventilator; PEEP Volume measured through airway release. FRC will be calculated as EELV minus PEEP volume. Correlation between EELV, PEEP volume, FRC at two different PEEP levels are tested by linear regression analysis.

次要结局

  • The change of driving Pressure(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)
  • The change of PaO2/FiO2 Ratio(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)
  • The change of regional EELV(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)
  • The change of blood pressure(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)
  • The change of homogeneity of distribution of tidal volume(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)
  • The change of regional FRC(1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Xin Zhou

Professor

Capital Medical University

研究点 (1)

Loading locations...

相似试验