Specialty: Critical care, Primary sub-specialty: Critical Care
Conditions
Interventions
Participants recruited to the study are randomised to either treatment group or control group.
Participants in control group receive standard care, while Participants in treatment gro
Sponsors
Royal Surrey County Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years, both male & female 2. Admitted to the ICU within the past 36 hours 3. Personal consultee provides declaration of agreement for patient enrolment, retrospective patient consent 4. Invasive mechanical ventilation 5. At least 2 other organ failures as defined by scoring =1 points on two of the SOFA score domains 6. Likely to remain on ICU for at least 4 days as classified by attending consultant
Exclusion criteria
Exclusion criteria: 1. Profound cardiovascular instability – infused vasopressors > = 0.5mcg/kg/min of norepinephrine; or in opinion of senior attending doctor 2. Profound coagulopathy (Prothrombin time> 2.5x normal or platelet count of 40); due to technical considerations. 7. Unlikely to survive ICU 8. Disseminated malignancy 9. Pregnancy 10. Previous, or current, DVT and PE 11. Positioned prone 12. Contraindication to pharmacological venous thromboembolism prophylaxis 13. Pre-existing significant cognitive impairment 14. Enrolled in a conflicting interventional trial 15. Lack ability to communicate in verbal and written English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of severe adverse events per participant in the control and treatment group are monitored from the time a personal consultee gives consent for the patient to participate in the study up to 3 months follow-up contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability is measured using pain on visual analog scale (VAS) at each ROS session 2.Feasibility to apply to ICU patients following is assessed using the success rate of screening potential eligible patients, Success rate of obtaining consent and recruiting patients, success rate of delivering ROS session as intended, success rate of performing outcome measure assessment as intended 3. Acceptability for patient, personal consultee and clinical staff is assessed using semi-structured interview at hospital discharge (patients and personal consultee) and at the end of study (clinical staff) 4. Difference in muscle function between control group and treatment group following will be assessed using: 4.1. Cross sectional area of rectus femoris muscle in right leg (control group) and both legs (treatment group) at day 1, 6 and 11 of ICU stay 4.2. Hand grip strength and other muscle group strength using MRC-Sum Score at day 6, 11 of ICU stay (or first day awakening) as well as at ICU and hospital discharge 4.3. Physical function assessment: ICU mobility scale (at day 1, 6, and 11 of ICU stay & ICU and hospital discharge), Sit to Stand & timed up and go (at hospital discharge only) 5. Difference in vascular function between control group and treatment group, reactive hyperaemic response and flow mediated dilatation of superficial femoral artery will be carried out on day 1, 6, 11 of ICU stay | — |
Countries
England, United Kingdom
Contacts
Public ContactBen Creagh-Brown
Outcome results
None listed