Analysis of Advanced Physiological Ventilatory Parameters During Spontaneous Breathing Effort in Patients with Acute Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
研究概览
简要总结
The aim of this prospective physiological cohort study conducted in a medical intensive care unit (ICU) at Hospital del Mar in Barcelona, Spain, was to analyze the proportion of time spent within the "safe" range of respiratory effort (including esophageal pressure swing (ΔPes), respiratory muscular pressure (Pmus), and transdiaphragmatic pressure swing (ΔPdi)) in patients with acute hypoxemic respiratory failure (AHRF) undergoing invasive mechanical ventilation (IMV), during the active breathing phase in relation to ICU survival.
The investigators hypothesized that AHRF patients on IMV with better outcome (i.e., ICU survivors) spend more time within the "safe" range of respiratory effort during the active breathing phase compared to non-survivors.
AHRF patients on IMV were continuously monitored with esophageal and gastric manometry from the detection of the onset of respiratory effort for up to 7 days, or until extubation, or until death, whichever occurred first.
详细描述
To characterize in detail the evolution of respiratory effort over time, the investigators conducted a prospective observational cohort study with continuous recordings of airway pressure, flow, esophageal and gastric pressures for up to 7 days after the onset of respiratory effort in AHRF patients on IMV.
Patients were classified into two groups: ICU survivors and ICU non-survivors. The primary objective of the study was to analyze the proportion of time spent within a specified "safe" range for Pmus, ΔPes, and ΔPdi (respiratory effort physiological variables), during spontaneous breathing, comparing both groups during the first 7 days after the initiation of respiratory effort. The secondary objective was to analyze the median values of ΔPes, Pmus, and ΔPdi during the monitorization period (active breathing phase) between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Acute hypoxemic respiratory failure patients requiring invasive mechanical ventialtion
排除标准
- •Presence of chest drains
- •Contraindication to esophageal catheterization (e.g., recent upper gastrointestinal surgery, bleeding esophageal varices)
- •Concomitant acute exacerbation of obstructive airways disease
结局指标
主要结局
Proportion of time spent in different ranges of Pmus (low, safe, and high) during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for Pmus was 5 to 15 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Proportion of time spent in different ranges of ΔPes (low, safe, and high) during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPes was -5 to -10 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Proportion of time spent in different ranges of ΔPdi (low, safe, and high) during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
The defined "safe" range for ΔPdi was 3 to 12 cm H2O. Effort outside the defined "safe" range was categorized as "low" if it fell below the lower limit, or "high" if it exceeded the upper limit of the safe range for the variable.
Median value of ΔPes during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPes during the active breathing phase between the two groups in cm H20.
Median value of Pmus during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of Pmus during the active breathing phase between the two groups in cm H20.
Median value of ΔPdi during the active breathing phase between the two groups
时间窗: From the start the start of respiratory effort up to 7 days (or until extubation or death, if earlier)
To analyze the median value of ΔPdi during the active breathing phase between the two groups in cm H20.
次要结局
- The need for the use of extracorporeal CO2 removal (ECCO2R)(From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months)
- Duration of invasive mechanical ventilation (IMV)(From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months)
- Intensive care Unit (ICU) Length of stay(From date of ICU admission until date of ICU discharge or date of death from any cause, whichever came first, assessed up to 24 months)
- The need for a Tracheostomy(From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months)
- The need for the use of venovenous (VV) extracorporeal membrane oxygenation (ECMO)(From date of initiation of invasive mechanical ventilation until extubation or date of death from any cause, whichever came first, assessed up to 24 months)
- Hospital Length of stay(From date of Hospital admission until date of Hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Andrea Castellvi
Clinical Investigator
Hospital del Mar