Beijing Rehabilitation Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100144, China
Location status: Recruiting
NCT Number: NCT07372794
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.
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All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100144, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: 28 days
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.
Time frame: 28 days
Successful liberation is defined as remaining free from invasive mechanical ventilation for at least 72 consecutive hours.
Time frame: Up to 28 days
Diaphragmatic excursion, thickness, and thickening fraction measured by bedside ultrasound.
Time frame: During intervention period (up to 28 days)
Regional ventilation distribution indices derived from electrical impedance tomography, analyzed as exploratory mechanistic outcomes and not used for primary outcome adjudication.
Time frame: Up to ICU discharge or day 28
Change in ICU Mobility Scale score from baseline to the highest achieved level during ICU stay.
Time frame: Up to hospital discharge
Number of days from ICU admission to ICU discharge.
Time frame: From hospital admission to hospital discharge
Number of days from hospital admission to hospital discharge.
Time frame: Up to hospital discharge
Total direct medical cost during hospitalization.
Time frame: During intervention period (up to 28 days)
Incidence of adverse events related to respiratory physiotherapy, including desaturation, hemodynamic instability, arrhythmia, or treatment intolerance.
Contact information is provided by the study sponsor or research team.
Capital Medical University
Other
Electrical Impedance Tomography-Guided Respiratory Physiotherapy for Liberation From Prolonged Mechanical Ventilation: A Multicenter Randomized Controlled Trial
Acronym: PMV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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