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

Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Respiratory Failure; Prolonged Mechanical Ventilation
• Intervention / Treatment: Other: EIT-Guided Respiratory Physiotherapy; Other: Conventional Respiratory Physiotherapy

Detailed Description

This multicenter randomized controlled trial evaluates the effectiveness of electrical impedance tomography (EIT)-guided respiratory physiotherapy compared with conventional respiratory physiotherapy in adult patients with prolonged mechanical ventilation (PMV).

Eligible patients receiving invasive mechanical ventilation for at least 21 consecutive days will be randomly assigned in a 1:1 ratio to either the EIT-guided group or the control group, in addition to standard ICU care.

Respiratory physiotherapy consists of airway clearance, chest physiotherapy techniques, breathing pattern optimization, and therapeutic positioning. Both groups will receive standardized physiotherapy protocols with comparable treatment frequency and duration.

In the EIT-guided group, real-time EIT imaging will be used during each physiotherapy session. The control group will receive the same standardized physiotherapy components according to institutional protocols without EIT guidance.

The primary outcome is ventilator-free days at day 28 (VFD-28), 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 will be considered treatment failure according to the predefined protocol.

Secondary outcomes include successful liberation from invasive mechanical ventilation by day 28, diaphragm ultrasound parameters, EIT-derived ventilation distribution indices (exploratory mechanistic outcomes), ICU Mobility Scale (IMS), healthcare resource utilization, and safety outcomes.

EIT-derived parameters are included as exploratory mechanistic outcomes to characterize physiological responses to the intervention and are not used for primary outcome adjudication.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Li; Phone Number: 86 13810913780; Email: liyi_bjkfyy@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100144
      • Recruiting
      • Beijing Rehabilitation Hospital Affiliated to Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EIT-Guided Respiratory Physiotherapy; 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; 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
Active Comparator: Conventional Respiratory Physiotherapy; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful liberation from invasive mechanical ventilation by day 28	Successful liberation is defined as remaining free from invasive mechanical ventilation for at least 72 consecutive hours.	28 days
Diaphragm ultrasound parameters	Diaphragmatic excursion, thickness, and thickening fraction measured by bedside ultrasound.	Up to 28 days
EIT-derived ventilation distribution indices	Regional ventilation distribution indices derived from electrical impedance tomography, analyzed as exploratory mechanistic outcomes and not used for primary outcome adjudication.	During intervention period (up to 28 days)
ICU Mobility Scale (IMS) change from baseline	Change in ICU Mobility Scale score from baseline to the highest achieved level during ICU stay.	Up to ICU discharge or day 28
ICU length of stay	Number of days from ICU admission to ICU discharge.	Up to hospital discharge
Hospital length of stay	Number of days from hospital admission to hospital discharge.	From hospital admission to hospital discharge
Total hospitalization cost	Total direct medical cost during hospitalization.	Up to hospital discharge
Adverse events during physiotherapy	Incidence of adverse events related to respiratory physiotherapy, including desaturation, hemodynamic instability, arrhythmia, or treatment intolerance.	During intervention period (up to 28 days)

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ventilator Weaning; Electrical Impedance Tomography; Prolonged Mechanical Ventilation; Ventilator-Free Days; Respiratory Physiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: 2026bkky0115ly

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No