Trial process | Outcome measure | Feasibility criteria |
---|---|---|
Screening | Percentage of potentially eligible patients being missed | < 55% of potentially eligible patients being missed |
Consent | Percentage of personal consultee/participants agreeing to enrolment | > 75% of personal consultees/participants agreeing to enrolment |
Recruitment rate | Number of patients recruited | Recruit 30 patients within 16 months |
Randomisation | Demographic and severity of illness in the intervention and control arms | Balanced demographic and severity of illness in intervention and control arm participants |
Delivery of intervention | Percentage of RVOS sessions performed out of the total possible sessions | 80% of the scheduled RVOS sessions performed |
Retention rate | Percentage of patients that remain on the ICU for the full 10 days of study enrolment | > 50% of enrolled patients remain on the ICU for the full 10 days of study enrolment |
Outcome measure assessments | Percentage of outcome measure assessments performed within 24 h of the scheduled time Percentage of quality-of-life questionnaires completed at 90-day follow-up | 100% of RFCSA ultrasound measurements performed within 24 h of the scheduled time > 75% of vascular, strength and functional capacity measures performed within 24 h of the scheduled time > 75% of surviving patients complete the quality-of-life questionnaires at 90-day follow-up |
Electronic case report form data collection | Percentage of missing outcome and clinical data | < 10% missing outcome data including ICU and hospital length of stay and survival < 10% missing clinical data obtained from clinical medical notes and electronic patient records, such as severity of illness scores and requirement for organ supportive therapies |