EIT-Guided Respiratory Physiotherapy for Prolonged Mechanical Ventilation (PMV)

NCT07372794 | Recruiting DMC

• 1 other identifier: 2026bkky0115ly
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with prolonged mechanical ventilation (PMV) frequently experience impaired ventilation distribution, respiratory muscle dysfunction, secretion retention, and delayed liberation from mechanical ventilation. Electrical impedance tomography (EIT) provides real-time bedside visualization of regional ventilation and enables individualized respiratory physiotherapy strategies. This multicenter randomized controlled trial aims to evaluate whether EIT-guided respiratory physiotherapy improves ventilator-free days at day 28 compared with conventional respiratory physiotherapy in adult patients with PMV. Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time EIT imaging is used to individualize physiotherapy strategies based on predefined ventilation distribution indicators, while the control group receives standardized physiotherapy according to institutional protocols without EIT guidance. Secondary outcomes include successful liberation from mechanical ventilation, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale, healthcare resource utilization, and safety outcomes.

Conditions

Prolonged Mechanical Ventilation; Respiratory Failure; Critical Illness

Keywords

Electrical Impedance Tomography; Prolonged Mechanical Ventilation; Respiratory Physiotherapy; Ventilator Weaning; Ventilator-Free Days

Outcome Measures

Primary Outcomes (1)

• Ventilator-Free Days at Day 28 (VFD-28)

  Ventilator-free days at day 28 (VFD-28) is defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before day 28 or remain invasively ventilated at day 28 will be assigned a value of zero. Reintubation within 72 hours after extubation or decannulation is considered treatment failure according to the predefined protocol.

  28 days

Secondary Outcomes (8)

• Successful liberation from invasive mechanical ventilation by day 28

  28 days

• Diaphragm ultrasound parameters

  Up to 28 days

• EIT-derived ventilation distribution indices

  During intervention period (up to 28 days)

• ICU Mobility Scale (IMS) change from baseline

  Up to ICU discharge or day 28

• ICU length of stay

  Up to hospital discharge

Study Arms (2)

EIT-Guided Respiratory Physiotherapy

EXPERIMENTAL

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. In the EIT-guided group, real-time electrical impedance tomography (EIT) imaging is used during each physiotherapy session to individualize patient positioning and the selection and sequencing of physiotherapy techniques based on predefined ventilation distribution indicators.

Other: EIT-Guided Respiratory Physiotherapy

Conventional Respiratory Physiotherapy

ACTIVE COMPARATOR

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance.

Other: Conventional Respiratory Physiotherapy

Interventions

EIT-Guided Respiratory Physiotherapy OTHER

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, individualized using real-time EIT guidance based on predefined ventilation distribution indicators. Link this intervention to: Experimental Arm

EIT-Guided Respiratory Physiotherapy

Conventional Respiratory Physiotherapy OTHER

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning, delivered according to standardized institutional protocols without EIT guidance. Link this intervention to: Control Arm

Conventional Respiratory Physiotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Invasive mechanical ventilation for ≥ 21 consecutive days.
• Clinically stable and eligible for respiratory physiotherapy as determined by the treating team.
• Expected to remain on invasive mechanical ventilation for at least 48 hours after enrollment.
• Written informed consent obtained from the patient or legally authorized representative.

You may not qualify if:

• Contraindications to electrical impedance tomography .
• Hemodynamic instability requiring high-dose vasoactive support.
• Severe hypoxemia refractory to optimization.
• Unstable fractures or other contraindications to mobilization or positioning.
• Pregnancy.
• Expected death within 48 hours.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100144, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Li

CONTACT

86 13810913780; liyi_bjkfyy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Physiotherapist

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 28, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-02

Locations

CN (1)