High protein diet and muscle rehab for patients on prolonged ventilation
The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients with Prolonged Mechanical Ventilation (PMV〕
NA · Chang Gung Memorial Hospital · NCT05932134
This study tests if a high protein diet, muscle rehab, and electrical stimulation can help patients who have been on a ventilator for a long time breathe on their own again more easily than just standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05932134 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a high protein diet, core muscle rehabilitation, and neuromuscular electrical stimulation (NMES) on patients who have been on mechanical ventilation for an extended period. Participants will be randomly assigned to one of four groups: usual care, usual care plus high protein diet, usual care plus high protein diet and muscle rehabilitation, or all three interventions including NMES. The study aims to determine if these interventions can improve the success rate of weaning patients off the ventilator compared to usual care alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older who have been on mechanical ventilation for more than 21 days and meet specific clinical stability criteria.
Not a fit: Patients with acute infections, severe neuromuscular diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the recovery and weaning process for patients on prolonged mechanical ventilation.
How similar studies have performed: While similar approaches have been explored, this specific combination of interventions in prolonged mechanical ventilation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan
- Department of Thoracic Medicine, Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prolonged Mechanical Ventilation, Protein Deficiency