Prolonged Mechanical Ventilation, Protein Deficiency
Conditions
Brief summary
The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are: * High protein formula intake benefit in successful weaning from ventilator * Core muscle rehabilitation benefit in successful weaning from ventilator * neuromuscular electric stimulation benefit in successful weaning from ventilator Participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES). Researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
Detailed description
The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator: * High protein formula intake benefit in successful weaning from ventilator * Core muscle rehabilitation benefit in successful weaning from ventilator * neuromuscular electric stimulation benefit in successful weaning from ventilator Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES). Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
Interventions
DIETARY_SUPPLEMENTUC + high protein diet (HP)
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
BEHAVIORALUC + HP + core muscle rehabilitation
Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks
DEVICEUC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \[range 50-65 mA\].
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES). Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. age ≥ 20 year old 2. using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube) 3. stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability) 4. maximal inspiratory pressure (MIP) \< 30mmHg 5. under enteral nutrition (EN) via NG tube.
Exclusion criteria
1. Acute infection and sepsis (fever up to 38.5 degree) 2. Severe neuromuscular disease, or uncontrolled epilepsy 3. Bony fracture or DVT history 4. Wound over the abdomen 5. Congestive heart failure with EF \< 40% or using pacemaker 6. BMI\>35 kg/M2, or severe edema 7. Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded. 8. Under parenteral nutrition (PN) 9. Use pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weaning Rate | 3 months | weaning success defined as weaning from ventilator for 5 consecutive days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In Hospital Mortality | 3 months | through the end of admission, up to 3 months |
| Length of Mechanical Ventilator Usage | 3 months | total ventilator use days in this admission |
| Length of ICU Stay | 6 months | total ICU stay in this admission |
Countries
Taiwan
Participant flow
Recruitment details
The inclusion criteria were as follows: 1. age ≥ 20 year old, 2. latest 21 days after their admission into the ICU, using mechanical ventilator for more than 21 days , 3. stable clinical condition, 4. maximal inspiratory pressure (MIP) \< 30mmHg, 5. under enteral nutrition (EN) via NG tube. We obtained written informed consent from the patients or their legally acceptable surrogate.
Pre-assignment details
According to the order of enrollment, patients will be randomly assigned into four groups: (1) Usual care (UC) + high protein diet (HP), (2) UC + HP + core muscle rehabilitation, (3) UC + HP + core muscle rehabilitation + neuromuscular electrostimulation (NMES) (4) UC. Patients were randomized accordingly using a table of random numbers and sealed envelopes. After randomization, on the first three day, we initiated interventions and maintained intervention for 21 days.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care as RCC protocol in Chang Gung Memorial hospital | 10 |
| UC + High Protein Diet (HP) The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. | 30 |
| UC + HP + Core Muscle Rehabilitation Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. | 30 |
| UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \[range 50-65 mA\]. | 30 |
| Total | 100 |
Baseline characteristics
| Characteristic | Usual Care | UC + High Protein Diet (HP) | UC + HP + Core Muscle Rehabilitation | UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 10.9 | 69.3 years STANDARD_DEVIATION 11.9 | 67.2 years STANDARD_DEVIATION 12.1 | 71.5 years STANDARD_DEVIATION 9.1 | 69.7 years STANDARD_DEVIATION 11.1 |
| modified Nutrition Risk in Critically ill (NUTRIC) score | 5.3 units on a scale STANDARD_DEVIATION 1.3 | 5.1 units on a scale STANDARD_DEVIATION 1.4 | 4.8 units on a scale STANDARD_DEVIATION 1.8 | 5.4 units on a scale STANDARD_DEVIATION 1.8 | 5.1 units on a scale STANDARD_DEVIATION 1.6 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 14 Participants | 14 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 16 Participants | 19 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 10 | 5 / 30 | 5 / 30 | 4 / 30 |
| other Total, other adverse events | 0 / 10 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 10 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Weaning Rate
weaning success defined as weaning from ventilator for 5 consecutive days
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual care | Weaning Rate | 3 Participants |
| UC + high protein diet (HP) | Weaning Rate | 20 Participants |
| UC + HP + core muscle rehabilitation | Weaning Rate | 22 Participants |
| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | Weaning Rate | 26 Participants |
Secondary
In Hospital Mortality
through the end of admission, up to 3 months
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual care | In Hospital Mortality | 3 Participants |
| UC + high protein diet (HP) | In Hospital Mortality | 5 Participants |
| UC + HP + core muscle rehabilitation | In Hospital Mortality | 5 Participants |
| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | In Hospital Mortality | 4 Participants |
Secondary
Length of ICU Stay
total ICU stay in this admission
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual care | Length of ICU Stay | 31.3 days | Standard Deviation 12.8 |
| UC + high protein diet (HP) | Length of ICU Stay | 25.7 days | Standard Deviation 7.9 |
| UC + HP + core muscle rehabilitation | Length of ICU Stay | 26.0 days | Standard Deviation 8.3 |
| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | Length of ICU Stay | 23.7 days | Standard Deviation 7.5 |
Secondary
Length of Mechanical Ventilator Usage
total ventilator use days in this admission
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual care | Length of Mechanical Ventilator Usage | 74.4 days | Standard Deviation 27.1 |
| UC + high protein diet (HP) | Length of Mechanical Ventilator Usage | 56.5 days | Standard Deviation 24.1 |
| UC + HP + core muscle rehabilitation | Length of Mechanical Ventilator Usage | 57.1 days | Standard Deviation 29.9 |
| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | Length of Mechanical Ventilator Usage | 41.1 days | Standard Deviation 12.9 |