Patients Are Recruited From One Thoracic and Cardiac Surgery ICU Clinical Trial
— TILTOfficial title:
Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
| Verified date | February 2017 |
| Source | Centre Chirurgical Marie Lannelongue |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | October 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Chirurgical MarieLannelongue | Le Plessis Robinson | Ile de France |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Chirurgical Marie Lannelongue |
France,
Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Review. — View Citation
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Medical Research Council, the patient is monitored and evaluate for up to 1 month | |
| Secondary | The time to standing | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | Duration ( time and every day), the patient is monitored and evaluate for up to 1 month | |
| Secondary | ICU stay | duration (day number), the patient is monitored and evaluate for up to 1 month | ||
| Secondary | Hospital stay | duration (day number), the patient is monitored and evaluate for up to 1 month | ||
| Secondary | Mechanical ventilation duration | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | time in minutes (every day), the patient is monitored and evaluate for up to 1 month | |
| Secondary | Hospital mortality | number of deaths | number of death during the 3 years of the study | |
| Secondary | 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. | Blood Pressure(mm Hg) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | |
| Secondary | 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. | heartt rate (beats a minute) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month | |
| Secondary | Onset of arrhythmia | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | irregular heart beat, every day the patient is monitored and evaluate for up to 1 month | |
| Secondary | Appearance of a disorder repolarization | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | ECG Interpretation, every day the patient is monitored and evaluate for up to 1 month | |
| Secondary | 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. | % saturation, every day, the patient is monitored and evaluate for up to 1 month | |
| Secondary | 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. | systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month | |
| Secondary | Pneumothorax detected immediately after standing session | This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital. | Chest radiography and clinical examination, every day the patient is monitored and evaluate for up to 1 month | |
| Secondary | 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. | observation evry day, the patient is monitored and evaluate for up to 1 month | |
| Secondary | 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. | observation, every day the patient is monitored and evaluate for up to 1 month |