Identification and Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS With Protection, Paralysis, and Proning: TheraPPP Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 19,916
- 试验地点
- 34
- 主要终点
- IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score
研究概览
简要总结
Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.
The overall objective of TheraPPP Pathway is to improve the quality of care for patients with HRF. Implementation of the pathway across Alberta will test the effectiveness and implementation of the TheraPPP Pathway.
详细描述
Hypoxemic respiratory failure (HRF) and ARDS are common conditions among patients admitted to the Intensive care unit (ICU). Treatment of these patients is complex. Evidence based therapies that can improve survival exist; however, implementation is extremely inconsistent. As a potential solution to this problem, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway to reduce practice variation and improve adherence to evidence-informed therapy.
The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The overall objective of the pathway is to improve the quality of care for patients with HRF. The specific objectives are to evaluate:
- Effectiveness of the pathway. A cost-effectiveness analysis is a secondary objective.
- Implementation of the pathway by conducting a process evaluation which will assess fidelity of the delivered interventions and clinician perceptions about the acceptability of the pathway.
Mechanically ventilated patients admitted to any one of 17 adult ICUs in Alberta will receive the intervention. One ICU (Calgary) is the setting for a pilot study (NCT04070053).
For data analysis, the investigators will use chart abstraction to quantitatively assess the fidelity of the delivered intervention, and surveys and focus groups to qualitatively assess clinician perceptions about the acceptability of the pathway. Fidelity of the intervention will be tracked using process of care indicators that reflect the five key steps of the pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Admitted to the one of the 17 adult Intensive Care Units in Alberta
- •Invasively mechanically ventilated
排除标准
- 未提供
结局指标
主要结局
IMPLEMENTATION (primary fidelity outcome) Composite Fidelity Score
时间窗: 4 months (after the study post-intervention period)
The composite fidelity score is measured daily for each patient. It is scored out of 5 and awards 1 point for each fidelity indicator (listed below) that investigators are able to measure: 1. If ventilated, is a height measured (step 1) 2. If arterial to inspired oxygen ratio (PaO2:FiO2 ratio or PF ratio) ≤300, is the medial tidal volume ≤8mL/kg (step 2) 3. If PF ratio ≤300, is a plateau pressure measured (step 3) 4. IF patient has HRF and PF ratio ≤150, was neuromuscular blockade used in that 24 hour period (step 4) 5. If the patient has HRF and PF ratio ≤150 and FiO2 ≥0.6, did the patient receive prone ventilation (step 5)
ECONOMIC (primary economic outcome) Cost per ventilator free day saved
时间窗: 4 months (after the study post-intervention period)
Cost per ventilator free day saved from the perspective of the health care system over the index hospitalization period
EFFECTIVENESS (primary clinical outcome) 28-day ventilator free days
时间窗: 4 months (after the study post-intervention period)
A composite outcome of survival and days spent not ventilated over the first 28 days
次要结局
- 28-day and hospital survival(90 days)
- Ventilator duration(4 months (after the study post-intervention period))
- Driving Pressure(4 months (after the study post-intervention period))
- Mechanical Power(4 months (after the study post-intervention period))
- Proportion of patient days with HRF and PF ratio ≤150 who receive neuromuscular blockade(4 months (after the study post-intervention period))
- Proportion of patient days with HRF and PF ratio ≤150 and FiO2 ≥0.6 receiving prone ventilation(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Opportunity costs construct(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Composite Acceptability Score(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Ethicality construct(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Self efficacy construct(4 months (after the study post-intervention period))
- ICU and hospital length of stay(4 months (after the study post-intervention period))
- Proportion of patients receiving rescue therapies specifically Extracorporeal Life Support (ECLS)(4 months (after the study post-intervention period))
- The proportion of patients ventilated with a height measured(4 months (after the study post-intervention period))
- Proportion of patient days with PF ratio ≤300 with a tidal volume ≤8mL/kg(4 months (after the study post-intervention period))
- Proportion of patient days with PF ratio ≤300 with a plateau pressure measured(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Perceived effectiveness construct(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Affective attitude construct(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Burden construct(4 months (after the study post-intervention period))
- Theoretical Framework of Acceptability - Intervention coherence construct(4 months (after the study post-intervention period))
- Total cost: ICU admission(4 months (after the study post-intervention period))
- Total cost: Index hospitalization(4 months (after the study post-intervention period))
- Cost per quality adjusted life year (QALY)(4 months (after the study post-intervention period))
研究者
Ken Kuljit Parhar, MD
Consultant Intensivist & Clinical Assistant Professor Affiliation: University of Calgary
University of Calgary