Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
Conditions
Keywords
Muscle Weakness, Exercise therapy, Physiotherapy, Critical illness, Intensive care, Mechanical ventilation, Rehabilitation
Brief summary
Critically ill patients frequently develop muscle weakness due to critical illness-related acute neuropathy and/or myopathy. This disorder is associated with difficulties in weaning from mechanical ventilation, prolonged intensive care unit and hospital stay, and increased mortality rates. In addition, many patients continue to suffer from decreased exercise capacity and quality of life for months to years after the acute event. Besides controlling risk factors, no specific prevention or treatment exists. Recommendations advice to start early with active and passive exercise in critically ill patients (1). Having critically ill patients alert and engaged in progressive rehabilitation leading to mobilization, despite the use of life support therapies may reduce muscle atrophy and lead to improved strength and physical function (2). This randomized controlled trial was designed to investigate whether a daily training session using a tilt table, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
Interventions
DEVICEthe standard physiotherapy group
Mobilization and rehabilitation program is progressively introduced after clinical stabilization
DEVICEstanding table group
The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform
Sponsors
Centre Chirurgical Marie Lannelongue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours
Exclusion criteria
* Polytrauma, * Cerebral , spinal cord or spinal injury, * Pelvic or lower limb fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used. | Medical Research Council, the patient is monitored and evaluate for up to 1 month | Clinically important muscle weakness has been defined as a composite MRC score \<80% of normal (eg, a score \<48 out of a maximum of 60 based on examination of 3 muscle groups in each limb). MRC score is measured after randomization, before ICU discharge and before hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | duration (day number), the patient is monitored and evaluate for up to 1 month | — |
| Hospital stay | duration (day number), the patient is monitored and evaluate for up to 1 month | — |
| Mechanical ventilation duration | time in minutes (every day), the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Hospital mortality | number of death during the 3 years of the study | number of deaths |
| Changes in blood pressure of more or less 20% of the reference value of rest required to stop the session or initiation of medical treatment | Blood Pressure(mm Hg) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Changes in heart rate of more or less 20% of the reference value of rest required to stop the session or initiation of medical treatment | heartt rate (beats a minute) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| The time to standing | Duration ( time and every day), the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Appearance of a disorder repolarization | ECG Interpretation, every day the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| desaturation of more than 10% of the reference value requiring a decision of the meeting or any medical intervention, | % saturation, every day, the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Increase in systolic pulmonary artery pressure more than 60 mmHg | systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Pneumothorax detected immediately after standing session | Chest radiography and clinical examination, every day the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Agitation requiring the increase of sedation or complicated tear gastric catheter probe or endotracheal tube, | observation evry day, the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Fall of the patient during a transfer | observation, every day the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
| Onset of arrhythmia | irregular heart beat, every day the patient is monitored and evaluate for up to 1 month | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. |
Countries
France
Outcome results
None listed