Timepoint | Study period | |||||
---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | |||
Day 0 | Day 1 | 3 months | 6 months | 12 months | 12 months | |
Enrolment: | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Interventions: | ||||||
NIPPV plus IOT | X | X | X | X | ||
NIPPV alone | X | X | X | X | ||
ASSESSMENTS: | ||||||
Demographics | X | |||||
Comorbidity | X | |||||
Vital signs | X | X | X | X | ||
Hospital readmission | X | X | X | X | ||
Exacerbation | X | X | X | X | ||
Survival status | X | X | X | X | ||
Arterial blood gases | X | X | X | X | ||
Lung function | X | X | ||||
SRI score | X | X | X | X | ||
CAT score | X | X | X | X | ||
mMRC score | X | X | X | X | ||
cNAT score | X | X | X | X | ||
Compliance | X | X | X | X | ||
Chest CT | X | X | ||||
Electrocardiogram | X | X | ||||
Echocardiography | X | X | ||||
Routine laboratory tests | X | X | ||||
Cost-effectiveness | X | X | X | X | ||
Safety | X | X | X | X |