Efficacy of Infection-site-targeted Postural Drainage in Mechanically Ventilated ICU Patients With Pulmonary Infection

NCT07821710 | Completed DMC

• 1 other identifier: AHJN-NURS-20240232
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Infection; Mechanical Ventilation; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  From initiation of invasive mechanical ventilation until successful extubation or death, assessed up to day 28.

Secondary Outcomes (4)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Procedure: Imaging-guided infection-site-targeted postural drainage plus mechanical vibration chest physiotherapy.

Routine-care group

ACTIVE COMPARATOR

Procedure: Routine position change combined with mechanical vibration

Interventions

Imaging-guided infection-site-targeted postural drainage plus mechanical vibration chest physiotherapy. PROCEDURE

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.

Intervention group

Routine position change combined with mechanical vibration PROCEDURE

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.

Routine-care group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years old;
• Admitted to ICU and receiving invasive mechanical ventilation;
• Clinically confirmed pulmonary infection;
• Enrolled between May 2022 and October 2024.

You may not qualify if:

• Unstable systemic disease contraindicating postural changes;
• Active bleeding (gastrointestinal, intracranial, or pulmonary);
• Requirement for continuous renal replacement therapy;
• Raised intracranial pressure;
• Neuromuscular disorder;
• Multiple fractures or major trauma;
• Severe hemodynamic instability;
• Significant arrhythmias;
• Severe delirium or altered mental status;
• Pregnancy or lactation;
• Currently participating in another interventional clinical trial.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead
• Wuxi Taihu Hospital: collaborator

Study Sites (1)

Wuxi Taihu Hospital

Wuxi, Jiangsu, 214003, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: May 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)