Potentially MOdifiable Factors To ImproVe Outcomes of Mechanically Ventilated Patients in ICUs in a Low-income Country: Rationale and Protocol for a Registry-embedded Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 625
- 主要终点
- ICU mortality
研究概览
简要总结
ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.
Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.
Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals.
详细描述
Introduction:
In low and middle-income countries (LMICs), up to two-thirds of ICU admissions necessitate invasive mechanical ventilation (IMV), compared to half of ICU admissions globally1-3. Though IMV is a life saving organ support technique, it's also linked to complications like ventilator associated lung injury and requires complex processes of care4. Despite being younger, ventilated patients in LMICs have 2-4 times higher mortality than high-income countries (HICs)5-8. Patients with acute respiratory distress syndrome (ARDS) in LMICs face an even greater risk, 70% higher than in HICs9.
While HICs have ample data on modifiable factors and improvement strategies that curtail ICU complications, LMICs may face preventable complications associated with IMV1,10-13. Complications like ventilator-induced lung injury and related pneumonia lead not only to excess deaths but also longer ICU stays and escalating costs14. Unfortunately, data on determinants of poor outcome among ventilated patients in LMICs remains scarce 12,15-17. Directly applying HIC evidence based management strategies to LMICs isn't always effective, as seen in several African trials 18,19. LMICs grapple with challenges like understaffing, limited training, insufficient infrastructure, and different patient characteristics and comorbidities, all potentially compromising the quality of ICU care15,16,20,21.
Recently, the use of critical care registries for data collection, including patient care, indicators, and outcomes, has expanded in both HICs and LMICs22-24. This streamlines research and offers cost benefits. Uganda has launched the Intensive Care Registry of Uganda (ICRU) for quality improvement and research infrastructure. This registry-embedded study aims to identify modifiable factors impacting outcomes for mechanically ventilated patients in LMICs leveraging ICRU's data pipeline. We hypothesize that specific patient-level and organizational factors can be identified that contribute to the ICU mortality of ventilated patients in Uganda.
Methods and Analysis:
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive mechanical ventilatory support initiated anywhere within the study hospital i.e., emergency room, normal ward or in the operating room, or in the ICU at any time during admission.
排除标准
- •Successful extubations within two calendar days of intubation
- •Admissions for end-of-life care and/or ICU palliative support
- •Patients transferred from ICUs not participating in the study 24 hours after initiation of MV.
- •Refusal or Withdrawal of consent
结局指标
主要结局
ICU mortality
时间窗: 28 days
Death at ICU discharge, or at 28 days after ICU admission, whichever occurs first.
ICU Length of Stay
时间窗: 28 days
Number of days patients spend in the ICU. Measured per episode of ICU care. Calculated using the interval (measured in hours) between the date and time of ICU admission and the date and time of ICU discharge. Rounded to the nearest 1 decimal place.
Duration of mechanical ventilation
时间窗: 28 days
The time between endotracheal intubation and successful extubation (in case of intermittent mechanical ventilation via a tracheostomy, every day a patient needs ventilation counts as one extra day, irrespective of the duration of ventilation on that specific day). In case of non-invasive ventilation, the duration will be assessed separated from the assessment of invasive ventilation.
次要结局
- Ventilator-free days(28 days)
- Ventilator-associated Pneumonia(28 days)
- ICU-Free days(28 days)
- Unplanned extubations(28 days)
- Readmission(28 days)
- Tracheostomy related outcomes(28 days)
- Duration of non-pulmonary organ support(28 days)
- Non-infectious Pulmonary complication(28 days)
- Tracheobronchitis(28 days)
研究者
Cornelius Sendagire
DR
Nat Intensive Care Surveillance - MORU