Intensive Care Unit-Acquired Weakness (ICU-AW)
Conditions
Interventions
A mobile treadmill with weight bearing utility will be used for BSTT in ICU
patients. The body weight-supported treadmill enables early ambulation in
patients with insufficient motor control or stre
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Medical and surgical adult patients (*18 years) admitted to the ICU or the MICU of the AMC who have been mechanically ventilated *48 hours
Exclusion criteria
Exclusion criteria: Contra indications for physical therapy treatment according to the Evidence Statement for ICU physical therapy (Sommers. et. al. 2013): o Recent myocardial ischemia o Hart frequency 130 * Blood pressure: o Map 110 mmHg Pulse oxymetry: * 90% Mechanical ventilation: o FiO2 *0.6 (60%) o PEEP* 10cm H2O Breathing frequency: o Frequency > 40 per minute Low consciousness: o RASS score: -4, -5, 3 or 4 Dose of inotropes: o Dobutamine > 20 mcg/kg/min o Dopamine > 10 mcg/kg/min o Nor/adrenaline * 0.1 mcg/kg/min Temperature: o * 38.5 degrees Celsius o *36 degrees Other: o Clinical observation by physical therapist: abnormal sweating, pain, fatigue o Surgical contra-indications (i.e. instable fractures, bone flap, open abdomen or thorax) o Presence of lines that prevent mobilization * Imminent to death, * Insufficient knowledge of the Dutch language, * Neurological diseases and disorders as reason for ICU admission, * One or more amputated lower extremities, * Mental retardation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters to evaluate feasibility are: - Eligibility criteria, proportion of enrolled patients of those who are screened. - Number and reasons of planned sessions that could not be executed; - Number and reasons of sessions that could not be completed sessions; - (Serious) Adverse Events ((S)AE*s); Adverse events: near falls, wounds, dislocation of tubes or lines and Serious adverse events ((S)AEs); - Effort and costs: Number of staff needed; Treatment duration, including preparation time, - Fatigue (measured with Borg score before and after BWSTT, as part of ususal physiotherapy care), Patient satisfaction; Pain (measured with the numeric raitng scale, before and after BWSTT, Anxiety measured with the numeric raitng scale before and after BWSTT). | — |
Secondary
| Measure | Time frame |
|---|---|
| The parameters to assess the effect size of potential outcome measures for the evaluation of BWSTT in ICU patients (future trial): - Acceleration of the first time to ambulation in ICU patients: Number of enrolled patients provided with the intervention who should not be able to walk without the intervention BWSTT - Walking capacity; Change in walking independence between start of BWSTT and at ICU /M-ICU discharge (measured with the De Morton Mobility Index (DEMMI) and Functional ambulation catergories (FAC) as part of usual physiotherapy care), Change in walking duration between start of BWSST and at ICU /M-ICU discharge, Body weight support (yes / no): change between first and last BWSTT - General muscle strength (MRC sum-score); change between start of BWSST and at ICU /M-ICU discharge as part of usual physiotherapy care. | — |
Countries
Netherlands
Outcome results
None listed