| Data | Timepoint | ||||||
---|---|---|---|---|---|---|---|---|
Enrollment | Baseline | Pre-intervention | During intervention | 5Â min post intervention | Duration of study period | 6-month follow-up | ||
Enrolment | Eligibility screening | X | Â | Â | Â | Â | Â | Â |
Consent | X | Â | Â | Â | Â | Â | Â | |
Allocation | X | Â | Â | Â | Â | Â | Â | |
Intervention | Standard care | Â | Â | Â | X | Â | Â | Â |
MI-E intervention | Â | Â | Â | X | Â | Â | Â | |
Assessments: baseline demographic outcome | Demographics (age, gender, predicted body weight, history of lung disease, smoking history) | Â | X | Â | Â | Â | Â | Â |
Reason for intubation | Â | X | Â | Â | Â | Â | Â | |
Date of hospital and ICU admission | Â | X | Â | Â | Â | Â | Â | |
Date of intubation | Â | X | Â | Â | Â | Â | Â | |
Ventilator settings | Â | X | Â | Â | Â | Â | Â | |
Airway type and size | Â | X | Â | Â | Â | Â | Â | |
APACHE II score | Â | X | Â | Â | Â | Â | Â | |
Assessments: clinical outcomes | Use of HFOT, NIV, tracheostomy | Â | Â | Â | Â | Â | X | Â |
Use of physiotherapy interventions | Â | Â | Â | X | Â | Â | Â | |
LUS score | Â | Â | X | Â | X | Â | Â | |
Patient pain/discomfort (CPOT; NRS) | Â | Â | X | Â | X | Â | Â | |
CVS parameters (HR, SBP, DBP) | Â | Â | X | Â | X | Â | Â | |
Ventilator parameters (vent settings, resistance, compliance) | Â | Â | X | Â | X | Â | Â | |
Respiratory parameters (RR, SpO2) | Â | Â | X | Â | X | Â | Â | |
Assessments: health economics | • Resource use (staffing requirements, suction frequency, consumable use, antibiotic use, physiotherapy on-call use) • QoL (EQ-5D-5L) |  |  |  | X |  |  | X |
Assessments: safety | Adverse events | Â | Â | Â | X | X | X | Â |