Clinical trial NCT02566941: Neuromuscular Electrical Stimulation in the Critically Ill
Official title: Neuromuscular Electrical Stimulation in the Critically Ill
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Polyneuropathy
Keywords: critical illness polyneuropathy
critical illness myopathy
neuromuscular electrical stimulation
intensive care unit acquired weakness
prevention of critical illness polyneuropathy
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of COPD (chronic obstructive pulmonary disease) patients (among others) to improve their resistance to efforts in everyday life. In patients in intensive care, it seems to improve strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days, with expected effects on the duration of hospitalization and the long-term functional outcome. Although its use could sometimes be limited by the development of peripheral edema and use of vasoconstrictors, the main advantage of this technique is the possibility of being used very early, even in patients that require deep sedation . This is extremely important given that the muscular atrophy process already starts 18h after the onset of invasive ventilation and as signs of impaired nerve transmission are developed in one third of patients at risk within 72 hours.

The purpose of the study is to assess the effects, in the short and medium term, of early neuromuscular stimulation in patients who are at higher risk of developing a critical illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.

This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.


Eligibility criteria: Inclusion Criteria:

* Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
* Aged over 18 years
* Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)\<200mmHg)
* SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.

Exclusion Criteria:

Definitive exclusion criteria:

* patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
* BMI superior to 35
* serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
* pregnant women
* patients admitted from Friday evening to Sunday morning

Temporary exclusion criteria:

* Hemodynamic instability (even with filling up and amines: noradrenaline \> 0.5y/kg/min and/or dobutamine \>5y/kg/min and/or adrenaline ivc)
* Extreme severity with suspicion of death within the first 24 h
* PIC \> 20 cmH2O
* Severe agitation (RASS \> +1)
* Curare utilisation within the last 24h

Primary outcomes:
measure: Duration of respiratory support
timeFrame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Length of stay in the intensive care unit
timeFrame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Type of hospital discharge
timeFrame: At hospital discharge, within a maximum of two years (approximate study length).
Secondary outcomes:
measure: cross-sectional area of the rectus femoris
timeFrame: First day in ICU
measure: cross-sectional area of the rectus femoris
timeFrame: Third day in ICU
measure: cross-sectional area of the rectus femoris
timeFrame: Fifth day in ICU
measure: cross-sectional area of the rectus femoris
timeFrame: Seventh day in ICU
measure: cross-sectional area of the rectus femoris
timeFrame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Force index - Grip test
timeFrame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Force index - Grip test
timeFrame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Force index - Bike
timeFrame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Force index - Bike
timeFrame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Electromyogram
timeFrame: First day of ICU admission
measure: Electromyogram
timeFrame: Third day of ICU admission
measure: Electromyogram
timeFrame: Fifth day of ICU admission
measure: Electromyogram
timeFrame: Seventh day of ICU admission
measure: Electromyogram
timeFrame: The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Physical Function ICU Test score (PFIT-s)
timeFrame: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Physical Function ICU Test score (PFIT-s)
timeFrame: the day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
measure: Six minutes Walking Test
timeFrame: the day the patient is discharged from the hospital, within a maximum of 2 years (approximate total study length)
measure: Six minutes Walking Test
timeFrame: one year after the day of admission to the intensive care unit
measure: MOS SF-36
timeFrame: the day the patient is discharged from the hospital, within a maximum of two years (approximated study lenght)
measure: MOS SF-36
timeFrame: one year after the day of admission to the intensive care unit
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Jacques Devriendt, MD
role: PRINCIPAL_INVESTIGATOR
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