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Completed

NCT Number: NCT02047617

Study of Safety and Efficacy on Neuromyopathy of Early Standing With the Assistance of Tilt Table in Critically Patients

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.

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Key information

Conditions

Patients Are Recruited From One Thoracic and Cardiac Surgery ICU Critical Illness Disease Attributes Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Chirurgical MarieLannelongue

Le Plessis-Robinson, Île-de-France Region, 92350, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the standard physiotherapy group

Device

Mobilization and rehabilitation program is progressively introduced after clinical stabilization

standing table group

Device

The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform

Primary outcomes

  1. 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

  1. The time to standing

    Time frame: 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.

  2. ICU stay

    Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month

  3. Hospital stay

    Time frame: duration (day number), the patient is monitored and evaluate for up to 1 month

  4. Mechanical ventilation duration

    Time frame: 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.

  5. Hospital mortality

    Time frame: number of death during the 3 years of the study

    number of deaths

  6. 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

    Time frame: 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.

  7. 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

    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

    This secondary endpoint is measured every day until the leaving of ICU and continued until leaving the hospital.

  8. Onset of arrhythmia

    Time frame: 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.

  9. Appearance of a disorder repolarization

    Time frame: 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.

  10. desaturation of more than 10% of the reference value requiring a decision of the meeting or any medical intervention,

    Time frame: % 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.

  11. Increase in systolic pulmonary artery pressure more than 60 mmHg

    Time frame: 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.

  12. Pneumothorax detected immediately after standing session

    Time frame: 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.

  13. Agitation requiring the increase of sedation or complicated tear gastric catheter probe or endotracheal tube,

    Time frame: 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.

  14. Fall of the patient during a transfer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Acronym: TILT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2014
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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