Clinical trial NCT02047617: Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
Official title: Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Are Recruited From One Thoracic and Cardiac Surgery ICU
Keywords: Muscle Weakness
Exercise therapy
Physiotherapy
Critical illness
Intensive care
Mechanical ventilation
Rehabilitation
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Measure of overall muscle strength, a composite Medical Research Council score (MRC score) from examination of 3 muscle groups in each limb is used.
timeFrame: Medical Research Council, the patient is monitored and evaluate for up to 1 month
Secondary outcomes:
measure: The time to standing
timeFrame: Duration ( time and every day), the patient is monitored and evaluate for up to 1 month
measure: ICU stay
timeFrame: duration (day number), the patient is monitored and evaluate for up to 1 month
measure: Hospital stay
timeFrame: duration (day number), the patient is monitored and evaluate for up to 1 month
measure: Mechanical ventilation duration
timeFrame: time in minutes (every day), the patient is monitored and evaluate for up to 1 month
measure: Hospital mortality
timeFrame: number of death during the 3 years of the study
measure: 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
timeFrame: Blood Pressure(mm Hg) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month
measure: 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
timeFrame: heartt rate (beats a minute) before and during standing session (every day). the patient is monitored and evaluate for up to 1 month
measure: Onset of arrhythmia
timeFrame: irregular heart beat, every day the patient is monitored and evaluate for up to 1 month
measure: Appearance of a disorder repolarization
timeFrame: ECG Interpretation, every day the patient is monitored and evaluate for up to 1 month
measure: desaturation of more than 10% of the reference value requiring a decision of the meeting or any medical intervention,
timeFrame: % saturation, every day, the patient is monitored and evaluate for up to 1 month
measure: Increase in systolic pulmonary artery pressure more than 60 mmHg
timeFrame: systolic pulmonary artery pressure (every day), the patient is monitored and evaluate for up to 1 month
measure: Pneumothorax detected immediately after standing session
timeFrame: Chest radiography and clinical examination, every day the patient is monitored and evaluate for up to 1 month
measure: Agitation requiring the increase of sedation or complicated tear gastric catheter probe or endotracheal tube,
timeFrame: observation evry day, the patient is monitored and evaluate for up to 1 month
measure: Fall of the patient during a transfer
timeFrame: observation, every day the patient is monitored and evaluate for up to 1 month
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical MarieLannelongue
state: Ile de France
Study officials:
affiliation: Centre Chirurgical Marie Lannelongue
name: Céline SARFATI, physiotherapist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer 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. Epub 2008 Feb 19.
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. Epub 2009 May 14.
citation: Sarfati C, Moore A, Pilorge C, Amaru P, Mendialdua P, Rodet E, Stephan F, Rezaiguia-Delclaux S. Efficacy of early passive tilting in minimizing ICU-acquired weakness: A randomized controlled trial. J Crit Care. 2018 Aug;46:37-43. doi: 10.1016/j.jcrc.2018.03.031. Epub 2018 Apr 5.