Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
- Conditions
- Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
- Registration Number
- NCT02047617
- Lead Sponsor
- Centre Chirurgical Marie Lannelongue
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- Patients who had been intubated and mechanically ventilated for more than 3 days, without weaning of ventilation sheduled in 24 hours
- Polytrauma,
- Cerebral , spinal cord or spinal injury,
- Pelvic or lower limb fracture
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
Centre Chirurgical MarieLannelongue
🇫🇷Le Plessis Robinson, Ile de France, France
Centre Chirurgical MarieLannelongue🇫🇷Le Plessis Robinson, Ile de France, France