High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

Study Overview
=================
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.

Official Title
-----------------
The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕

Conditions
-----------------
Prolonged Mechanical Ventilation, Protein Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: UC + high protein diet (HP)
* Behavioral: UC + HP + core muscle rehabilitation
* Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20 year old using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube) 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) maximal inspiratory pressure (MIP) < 30mmHg under enteral nutrition (EN) via NG tube. Exclusion Criteria: Acute infection and sepsis (fever up to 38.5 degree) Severe neuromuscular disease, or uncontrolled epilepsy Bony fracture or DVT history Wound over the abdomen Congestive heart failure with EF < 40% or using pacemaker BMI>35 kg/M2, or severe edema Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded. Under parenteral nutrition (PN) Use pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care as RCC protocol in Chang Gung Memorial hospital | |
| Experimental: UC + high protein diet (HP)<br>The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. | Dietary Supplement: UC + high protein diet (HP)<br>* The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.<br>|
| Experimental: UC + HP + core muscle rehabilitation<br>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. | Behavioral: UC + HP + core muscle rehabilitation<br>* Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks<br>|
| Experimental: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)<br>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]. | Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)<br>* 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].<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning rate | weaning success defined as weaning from ventilator for 5 consecutive days | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In hospital mortality | Mortality event in this admission | 6 months | 
| Length of mechanical ventilator usage | total ventilator use days in this admission | 3 months | 
| Length of ICU stay and total length of hospitalization | total ICU stay and hospitalization days | 6 momnths |