Critical Illness Clinical Trial
— MOTIVATE-ICUOfficial title:
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
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.
Status | Not yet recruiting |
Enrollment | 625 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Nat Intensive Care Surveillance - MORU | D'Or Institute for Research and Education, Makerere University, University of Oxford, Wellcome Trust |
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* Note: There are 50 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU mortality | Death at ICU discharge, or at 28 days after ICU admission, whichever occurs first. | 28 days | |
Primary | ICU Length of Stay | 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. | 28 days | |
Primary | Duration of mechanical ventilation | 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. | 28 days | |
Secondary | Duration of non-pulmonary organ support | Time between initiation of vasopressor/inotropic support or renal replacement therapy to the time of discontinuation for at least 24 hours. Individual components of the composite outcome will be reported. | 28 days | |
Secondary | ICU-Free days | Number of in-hospital days from ICU discharge to 28 days. If the patient dies after ICU discharge and before 28 days this will count as 0 | 28 days | |
Secondary | Ventilator-free days | The number of ventilator-free days at 28 days (VFD-28) will be determined by subtracting the total duration of mechanical ventilation from 30 days. If a patient passed away before reaching the 28-day mark, their VFD-28 will be recorded as having zero VFD-28 | 28 days | |
Secondary | Ventilator-associated Pneumonia | Presence of fever OR Altered leukocyte count PLUS New onset of purulent endotracheal secretions OR change in sputum WITH new and progressive or persistent infiltrate or consolidation or cavitation48 For those without radiological diagnosis, we shall consider clinically suspected VAP. | 28 days | |
Secondary | Tracheobronchitis | Presence of fever OR altered leukocyte count (<4 or >12 x 103) PLUS New onset of purulent endotracheal secretions OR change in sputum | 28 days | |
Secondary | Non-infectious Pulmonary complication | Clinician suspicion or radiological diagnosis of pleural effusion, atelectasis or pneumothorax | 28 days | |
Secondary | Readmission | Unplanned ICU admission within 48 hours after ICU discharge | 28 days | |
Secondary | Unplanned extubations | Inadvertent/accidental extubations requiring reintubation | 28 days | |
Secondary | Tracheostomy related outcomes | The following outcomes will be included:
Timing of tracheostomy in terms of number of days after intubation; decannulation rate, i.e. the proportion of patients undergoing successful decannulation during ICU stay decannulation failure (defined as the need to recannulate for any reason between decannulation and hospital discharge); Tracheostomy-related complications: stoma infection, major bleeding, tube dislodgement, and malfunction defined as air leaks |
28 days |
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