Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
- Sponsor
- Centre Chirurgical Marie Lannelongue
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used.
Time Frame: 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 Outcomes
- The time to standing(Duration ( time and every day), the patient is monitored and evaluate for up to 1 month)
- 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)
- Hospital mortality(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(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(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(irregular heart beat, every day the patient is monitored and evaluate for up to 1 month)
- Appearance of a disorder repolarization(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,(% saturation, every day, the patient is monitored and evaluate for up to 1 month)
- 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)
- Pneumothorax detected immediately after standing session(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,(observation evry day, the patient is monitored and evaluate for up to 1 month)
- Fall of the patient during a transfer(observation, every day the patient is monitored and evaluate for up to 1 month)