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Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning

Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06677099
Enrollment
80
Registered
2024-11-06
Start date
2024-11-07
Completion date
2025-12-30
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult-to-Wean Patients

Keywords

mechanical ventilation, electrical impedance tomography

Brief summary

Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.

Interventions

PROCEDUREchest physiotherapy

Two sessions of CPT (morning and afternoon, 20 minutes each) were conducted. The CPT session consisted of modified postural drainage, assisted cough technique , positive expiratory pressure and chest percussion, vibration. The appointed therapist performed pulmonary auscultation and thoracic palpation to assess the status of pulmonary ventilation and secretion retention, and whether the patient's cough ability can complete effective airway clearance. Individualized program was formed according to the assessment, internal guidelines, the patient's tolerance, education level, and patient's preference prior to the randomization. All CPT sessions were performed by the same physiotherapist to avoid potential bias.

PROCEDUREEIT-guided chest physiotherapy

EIT-guided modified postural drainage combined with vibrations and chest percussion: tidal variation images in EIT reveals heterogeneously ventilated regions. Physiotherapist identified such regions at the bedside and instructed the patient to take the appropriate drainage position, so that the poorly ventilated regions became gravity non-dependent regions. Subsequently, the physiotherapist put her hands on the poorly ventilated area with a vibratory force. A compressive pressure was produced by the therapist's arms.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation), * willing to participate in the study and sign the informed consentsent.

Exclusion criteria

* Malignant arrhythmia or acute myocardial ischemia * Pneumothorax, pulmonary bulla and barotrauma and other lung diseases * Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency * Chest skin trauma * Pulmonary hypertension and pulmonary embolism * With a permanent or temporary pacemaker * There is malignant tumor * Present and previous history of neuromuscular diseases affecting respiratory muscle * Participated in another clinical study related to mechanical ventilation withdrawal * Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.

Design outcomes

Primary

MeasureTime frame
peak expiratory flowAll data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)

Secondary

MeasureTime frame
Maximum inspiratory pressureAll data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragm thickening rateAll data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
The cumulative incidence of successful weaning by Day 30from admission to discharge, assessed up to 1 day
Length of ICU stayfrom admission to discharge, assessed up to 1 day
Cumulative incidence for death before successful weaningfrom admission to discharge, assessed up to 1 day
Diaphragmatic excursionAll data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)

Contacts

Primary ContactJingyi Ge
ge_jingyi2020@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026