TEAM Trial – Early Mobilisation in Intensive Care

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  TEAM Trial – Early Mobilisation in Intensive Care
  Dr Swapnil Pawar

Early Active Mobilization during Mechanical Ventilation in the ICU

• The TEAM Study Investigators and the ANZICS Clinical Trials Group

Blog Written by – Dr Jose Chacko

Population and setting

The study was held from February 27, 2018, to November 19, 2021, across 49 hospitals in 6 countries, including Australia, New Zealand, Ireland, the UK, Germany, and Brazil. Patients were on mechanical ventilation. Ventilation was expected to continue beyond the calendar day after randomization. Patients were judged to be stable to enable mobilization.

Could be on norepinephrine ≤0.2 mcg/kg/min, respiratory rate ≤45/min PEEP ≤16

Excluded

Dependence for activities of daily living in the month preceding hospitalization; orders for bed rest, acute brain or spinal cord injury

Intervention

Early mobilization

Minimization of sedation and physiotherapy in one or two sessions. The highest level of therapy is followed by scale down in case of fatigue. Validation scale of 0–10, 0 for immobility and 10 for walking independently.

Attempt to mobilize patients out of bed (IMS ≥3). This corresponds to sitting over the edge of with trunk control; assistance by staff if required.

Exercises on the bed itself if they did not meet the criteria for out-of-bed mobilization.

Control

Usual care and level of mobilization are generally provided at each site and carried out by a different set of staff if possible.

The trial protocol was continued for the duration of the ICU stay for up to 28 days after randomization.

Sample size

The primary outcome was days alive and out of hospital at 180 days. The sample size was calculated for 90% power to detect a 7-day difference in the primary outcome, with a two-sided alpha of 0.05. Allowing a nonparametric distribution and 5% loss to follow-up, the calculated sample size was 750 patients.

Results

A total of 750 patients were randomized. The primary outcome data were available 369/372 patients in the early mobilization group and 364/378 patients in the usual care group. Patients were well-matched at baseline. Approximately 62% of patients were on some dose of vasopressors and 22% on RRT. 97% of patients were on infusion with sedative agents.

The mean daily duration of active mobilization: 20.8±14.6 vs. 8.8±9.0 minutes in the usual care. (Absolute difference, 12 minutes per day; 95% confidence interval [CI], 10.4 to 13.6).

Process-of-care measures: tracheostomy, neuromuscular blockers, glucocorticoids, new renal-replacement therapy, re-intubation, and vasopressor-free days — were similar in the two groups

Outcome	Early mobilization (371)	Usual care (370)	Significance
Alive and out of hospital* at 180 d	143 days (21–161)	145 days (51–164)	−2.0 (−10 to 6) p = 0.62
Mortality at 180 days	83/369 (22.5%)	71/364 (19.5%)	OR, 1.15; 95% CI, 0.81–1.65
Number of ventilator-free days from randomization to day 28#	No significant difference
No of ICU-free days from randomization to day 28#	No significant difference

*The number of days at home or in accommodation other than a health care facility (rehabilitation hospital or nursing home). Days alive and out of hospital at 180 days = 0 if death occurred before 180 days

#The number of ventilator-free and ICU-free days at day 28 counted as zero if death occurred before 28 days

Patient-reported outcome measures, including quality of life and function in survivors, were

evaluated at day 180.

The following indices were used to assess the quality of life

• The EQ Visual Analogue Scale provided a global rating of patient-perceived health from 0 to 100, with higher scores indicating better health
• Barthel Activities of Daily Living (ADL) Index
• Lawton Instrumental Activities of Daily Living Scale (IADL)
• World Health Organization Disability Assessment Schedule (WHODAS 2.0)

Patient-reported outcomes were available in 286 patients in the early-mobilization group and 293 in the usual-care group. Findings regarding the quality of life, activities of daily living, and disability were similar between groups

Adverse events

Evaluated prespecified adverse events, including falls to the floor, cardiac arrest, atrial fibrillation with a ventricular response of more than 150 bpm, other dangerous arrhythmias, oxygen-saturation level on pulse oximetry of less than 80% for more than 3 minutes, and unplanned extubation or removal of the intravascular line resulting in urgent replacement.

Adverse events that were potentially due to mobilization (arrhythmias, altered blood pressure, and desaturation) were reported in 34 of 371 patients (9.2%) in the early-mobilization group and in 15 of 370 patients (4.1%) in the usual-care group (P=0.005).

Serious adverse events

A total of 8 serious adverse events were reported, of which 7 occurred in the early-mobilization group (5 arrhythmias, a desaturation episode, and a cerebrovascular accident), and 1 occurred in the usual-care group (a desaturation episode). All serious adverse events required intervention. All were reversed except for the patient with a cerebrovascular accident who had a persistent weakness. No incidence of falls, cardiac arrest, unplanned extubation, or intravascular line removal resulting in urgent replacement

Comments/limitations

• Some patients in the cohort could not be mobilized according to plan
• Missing data (withdrew consent or lost to follow up)
• Does the “usual care” of the study apply to a general ICU setting?
• Would a specific subgroup of patients benefit from early mobilization?
• More research required to decide on timing, intensity, and duration of mobilization
• Important to note that the study compared two levels of mobilization and found no difference on outcomes. It should not be inferred that early mobilization is not beneficial. Besides, although the duration of mobilization was greater in the early group, the intensity was similar in both groups. This may have contributed to the apparent lack of benefit with early mobilization.
• The difference between early mobilization and usual care may have been not substantially different in some of the centers
• Will a mobilization strategy focused during ICU stay alone make a difference? Perhaps more crucial would be the rehabilitation phase once out of the ICU
• The primary outcome of days alive and out of hospital at 180 days may be an unrealistic outcome to aim for with an early mobilization strategy.

Our recommendation –

It’s essential not to STOP mobilising your patients based on the trial results.

It will be helpful to personalise early mobilisation strategies in a select subgroup of patients to avoid adverse events associated with early mobilisation.

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