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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Protein Deficiency; Prolonged Mechanical Ventilation

Treatments: Behavioral: UC + HP + core muscle rehabilitation; Dietary Supplement: UC + high protein diet (HP); Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

Study type: Interventional

Funder types: Other

Identifiers

NCT05932134

202300154A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 4 patient groups

Usual care

No Intervention group

Description:

Usual care as RCC protocol in Chang Gung Memorial hospital

UC + high protein diet (HP)

Experimental group

Description:

The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

Treatment:

Dietary Supplement: UC + high protein diet (HP)

UC + HP + core muscle rehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: UC + HP + core muscle rehabilitation

UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

Experimental group

Description:

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 \[range 50-65 mA\].

Treatment:

Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)