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NCT Number: NCT06677099

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

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.

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Key information

Conditions

Difficult-to-Wean Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),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.

Treatment and study plan

Chest physiotherapy

Procedure

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.

EIT-guided chest physiotherapy

Procedure

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.

Primary outcomes

peak expiratory flow

Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)

Secondary outcomes

The cumulative incidence of successful weaning by Day 30

Time frame: from admission to discharge, assessed up to 1 day
Maximum inspiratory pressure

Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragm thickening rate

Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Diaphragmatic excursion

Time frame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Length of ICU stay

Time frame: from admission to discharge, assessed up to 1 day
Cumulative incidence for death before successful weaning

Time frame: from admission to discharge, assessed up to 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Jingyi Ge

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 6, 2024
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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.