Rehabilitation of Patients From the ICU to the Post-hospital Phase

Launched by UNIVERSITY OF SAO PAULO · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of early and intense mobilization and rehabilitation for patients who have been critically ill and on mechanical ventilation in the ICU. The goal is to see how this approach can improve patients' physical abilities, reduce inflammation, lower costs, and ultimately decrease the risk of death. Participants will be divided into two groups: one will do 30 to 60 minutes of exercises each day, while the other will do 10 minutes. After leaving the hospital, both groups will receive continued support and assessment to track their recovery over the following months.

To be eligible for the trial, participants must be 21 years or older, have been on mechanical ventilation for at least 48 hours, and be stable enough to safely participate in mobility exercises. Certain medical conditions, such as severe cognitive impairments or specific heart and lung issues, may exclude individuals from participating. Those who join can expect to engage in a structured rehabilitation program that aims to enhance their recovery and quality of life after a serious illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Both sexes
• • Age greater than or equal to 21 years
• • Be on invasive mechanical ventilation (IMV) for at least 48 hours
• • Sufficient cardiovascular stability for mobilization
• • 1. Absence of bradyarrhythmia (\< 50 bpm);
• • 2. Heart rate ≥ 150 bpm;
• • 3. Most recent lactate measurement ≤ 4.0mmol/L;
• • 4. Combined adrenaline/noradrenaline infusion rate ≤ 0.2mcg/Kg/min, OR if the adrenaline/noradrenaline infusion was increased by more than 25% in the last 6 hours;
• • 5. Cardiac index ≥ 2.0L/min/m2; when evaluated
• • Respiratory stability sufficient for mobilization f) Respiratory rate ≤ 45rpm; g) FiO2 ≤ 0.6; h) PEEP ≤ 16 cmH2O; i) No need for NO (nitric oxide), prone position, neuromuscular blocker, ECMO (extracorporeal membrane oxygenation) or HFOV (high frequency ventilation).
• Exclusion Criteria:
• • Dependent for ADLs in the month prior to ICU admission;
• • Diagnosed cognitive deficit;
• • Diagnosis OR suspicion of acute primary brain disease (TBI, stroke);
• • Diagnosis OR suspected spinal cord injury OR other neuromuscular disease that may result in prolonged or permanent muscle weakness (except muscle weakness acquired in the ICU);
• • Need OR instructions to remain in bed OR not to bear weight on the lower limbs bilaterally;
• • Life expectancy of less than 180 days due to acute or chronic clinical conditions;
• • Death considered inevitable due to current clinical condition or if the patient/clinical guardian is not committed to complete active treatment (e.g. brain death);
• • Inability to communicate in Portuguese;
• • Readmission to the ICU of the same hospital service;
• • Pregnant women;
• • Patients with a permanent pacemaker.