Mechanical Ventilation, Pulmonary Infection, Respiratory Failure
Conditions
Brief summary
This single-center, 1:1 randomized controlled trial aimed to evaluate the efficacy of infection-site-targeted postural drainage combined with mechanical vibration for mechanically ventilated ICU patients with pulmonary infection. Eligible subjects were randomly assigned to either the personalized-care group (PCG, intervention) or routine-care group (RCG, control). Patients in PCG received imaging-guided infection-site-targeted postural drainage plus mechanical vibration. Patients in RCG received standard routine position changes and mechanical vibration without imaging-guided targeted positional adjustment. The primary outcome was duration of invasive mechanical ventilation. Secondary outcomes included PaO₂/FiO₂ ratio, ICU length of stay, total hospital length of stay, and 28-day all-cause mortality.
Interventions
PROCEDUREImaging-guided infection-site-targeted postural drainage plus mechanical vibration chest physiotherapy.
Imaging-guided infection-site-targeted postural drainage combined with mechanical vibration chest physiotherapy. The body position is individually adjusted according to pulmonary infection location shown on imaging examinations to facilitate sputum drainage.
PROCEDURERoutine position change combined with mechanical vibration
Routine regular position change combined with mechanical vibration chest physiotherapy. No imaging-guided targeted positional adjustment is performed; body position is changed following standard ICU nursing protocol only.
Sponsors
Affiliated Hospital of Jiangnan University
Wuxi Taihu Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-80 years old; 2. Admitted to ICU and receiving invasive mechanical ventilation; 3. Clinically confirmed pulmonary infection; 4. Enrolled between May 2022 and October 2024.
Exclusion criteria
1. Unstable systemic disease contraindicating postural changes; 2. Active bleeding (gastrointestinal, intracranial, or pulmonary); 3. Requirement for continuous renal replacement therapy; 4. Raised intracranial pressure; 5. Neuromuscular disorder; 6. Multiple fractures or major trauma; 7. Severe hemodynamic instability; 8. Significant arrhythmias; 9. Severe delirium or altered mental status; 10. Pregnancy or lactation; 11. Currently participating in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation | From initiation of invasive mechanical ventilation until successful extubation or death, assessed up to day 28. |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality | All-cause mortality assessed at 28 calendar days from the date of randomization |
| PaO₂/FiO₂ ratio | Measured at baseline (X1), Day 1, Day 2, Day 3, Day 4 post-randomization (X2-X4), and at weaning preparation (X5), all within 28 calendar days from randomization |
| ICU length of stay | From randomization until ICU discharge, assessed up to 28 calendar days from randomization |
| Total hospital length of stay | From randomization until hospital discharge, assessed up to 28 calendar days from randomization |
Countries
China
Outcome results
None listed