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临床试验/NCT07172061
NCT07172061已完成不适用

Sigh in Pressure Support Ventilation to Detect Respiratory System Compliance and Lung Recruitability

AUSL Romagna Rimini2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Sigh-to-Assisted Breath Respiratory System Compliance Ratio (Crs_sigh/Crs_assisted)

研究概览

简要总结

The goal of this physiological study is to determine whether ventilator-delivered sigh breaths during pressure support ventilation (PSV) provide a reliable bedside index of lung recruitability and can guide PEEP optimization.The main questions it aims to answer are:

  • Does respiratory system compliance measured at the end of a sigh (Crs_sigh) differ from compliance obtained with an inspiratory hold during an assisted breath (Crs_assisted), and can the Crs_sigh/Crs_assisted ratio indicate recruitability?
  • Does adjusting PEEP based on the sigh-derived recruitability index improve respiratory mechanics and gas exchange compared with usual clinical PEEP settings?

详细描述

Background and RationaleInvasive mechanical ventilation is often necessary in critically ill adults but may contribute to ventilator-induced lung injury (VILI) if ventilator settings are not individualized. During assisted ventilation (pressure support ventilation, PSV), ongoing patient effort complicates the assessment of PEEP response, PEEP titration, and lung recruitability.Ventilator-delivered sigh breaths (i.e., brief sustained inflations) can improve gas exchange and promote alveolar recruitment, and may permit artifact-free assessment of respiratory mechanics in assisted modes. This study evaluates whether Crs measured at the end of a sigh provides reliable, clinically useful information on recruitability and whether the ratio of Crs during sigh to Crs during an assisted breath (Crs_sigh/Crs_assisted) can guide positive end-expiratory pressure (PEEP) optimization.Primary ObjectiveTo assess lung recruitability during PSV by normalizing Crs measured at the end of a sigh to Crs obtained with an inspiratory hold during an assisted breath.Secondary Objectives

  • To quantify the proportion of patients in whom Pplat during assisted breathing is not reliable (non-readable or unstable ≥3 s).
  • To determine whether adjusting PEEP according to the sigh-derived recruitability index improves Crs.

Inclusion criteria:Adults (≥18 years) receiving PSV with the ventilator's sigh function active.Exclusion criteria:

  • Clinical contraindication to increasing PEEP
  • Hemodynamic instability defined as SOFA cardiovascular score ≥3

Protocol OverviewEach participant undergoes two sequential, non-randomized steps:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
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
否

入选标准

  • •Adults (≥18 years) receiving PSV with the ventilator's sigh function active.

排除标准

  • •Clinical contraindication to increasing PEEP
  • •Hemodynamic instability defined as SOFA cardiovascular score ≥3

研究组 & 干预措施

Clinical PEEP (baseline)

Experimental

Pressure support ventilation (PSV) at the clinical PEEP with ventilator-delivered sighs: one sustained inflation at 30 cmH₂O for 3 seconds every minute.

干预措施: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) (Other)

Clinical PEEP +3 cmH₂O

Experimental

Pressure support ventilation (PSV) with PEEP set 3 cmH₂O above the clinical PEEP, with ventilator-delivered sighs: one sustained inflation at 30 cmH₂O for 3 seconds every minute.

干预措施: PSV + sigh (Clinical PEEP and Clinical PEEP + 3 cmH₂O) (Other)

结局指标

主要结局

Sigh-to-Assisted Breath Respiratory System Compliance Ratio (Crs_sigh/Crs_assisted)

时间窗: End of each 15-minute step within a single study session (clinical PEEP; clinical PEEP +3 cmH₂O).

Ratio of respiratory system compliance at the end of a ventilator-delivered sigh to compliance measured during an inspiratory hold on an assisted tidal breath. This normalized metric indexes recruitability during assisted ventilation; higher values indicate greater recruitability. The primary analysis is the within-patient change in the ratio from clinical PEEP to clinical PEEP +3 cmH₂O.

次要结局

  • Patients with unreliable plateau pressure during assisted breaths(Across both 15-minute steps within the single study session.)
  • Association between sigh-derived recruitability index and change in respiratory system compliance(End of each 15-minute step within the single study session)

研究者

发起方
AUSL Romagna Rimini
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Bastia

MD

AUSL Romagna Rimini

研究点 (2)

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