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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
145
Mobilization and rehabilitation program is progressively introduced after clinical stabilization
The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform
Centre Chirurgical MarieLannelongue
Le Plessis-Robinson, Île-de-France Region, France
Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used.
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.
Time frame: Medical Research Council, the patient is monitored and evaluate for up to 1 month
The time to standing
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: Duration ( time and every day), the patient is monitored and evaluate for up to 1 month
ICU stay
Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month
Hospital stay
Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month
Mechanical ventilation duration
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: time in minutes (every day), the patient is monitored and evaluate for up to 1 month
Hospital mortality
number of deaths
Time frame: number of death during the 3 years of the study
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
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: Blood Pressure(mm Hg) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month
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
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: heartt rate (beats a minute) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month
Onset of arrhythmia
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: irregular heart beat, every day the patient is monitored and evaluate for up to 1 month
Appearance of a disorder repolarization
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: ECG Interpretation, every day the patient is monitored and evaluate for up to 1 month
desaturation of more than 10% of the reference value requiring a decision of the meeting or any medical intervention,
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: % saturation, every day, the patient is monitored and evaluate for up to 1 month
Increase in systolic pulmonary artery pressure more than 60 mmHg
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month
Pneumothorax detected immediately after standing session
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: Chest radiography and clinical examination, every day the patient is monitored and evaluate for up to 1 month
Agitation requiring the increase of sedation or complicated tear gastric catheter probe or endotracheal tube,
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: observation evry day, the patient is monitored and evaluate for up to 1 month
Fall of the patient during a transfer
This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.
Time frame: observation, every day the patient is monitored and evaluate for up to 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.