Clinical trial NCT05932134: High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation
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〕
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolonged Mechanical Ventilation
Protein Deficiency
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weaning rate
timeFrame: 3 months
Secondary outcomes:
measure: In hospital mortality
timeFrame: 6 months
measure: Length of mechanical ventilator usage
timeFrame: 3 months
measure: Length of ICU stay and total length of hospitalization
timeFrame: 6 momnths
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
References:
citation: Huang SW, Lin HC, Chou YF, Lin TY, Lo CY, Huang HY, Fang YF, Hsieh MH, Lin SM, Lo YL, Hsieh MJ, Kao KC, Lin CY, Huang CC. The Impact of Higher Protein Intake in Patients with Prolonged Mechanical Ventilation. Nutrients. 2022 Oct 20;14(20):4395. doi: 10.3390/nu14204395.