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

Protein Deficiency Clinical Trial

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〕

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932134
• Other study ID #: 202300154A3
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: March 21, 2025

Study information

• Verified date: April 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 21, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Mechanical Ventilation
• Protein Deficiency

Intervention

Dietary Supplement:
• UC + high protein diet (HP)
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

Behavioral:
• UC + 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

Device:
• 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].

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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: 10.33 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning rate	weaning success defined as weaning from ventilator for 5 consecutive days	3 months
Secondary	In hospital mortality	Mortality event in this admission	6 months
Secondary	Length of mechanical ventilator usage	total ventilator use days in this admission	3 months
Secondary	Length of ICU stay and total length of hospitalization	total ICU stay and hospitalization days	6 momnths