Clinical trial NCT06677099: Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning
Official title: Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difficult-to-Wean Patients
Keywords: mechanical ventilation
electrical impedance tomography
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),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

Primary outcomes:
measure: peak expiratory flow
timeFrame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
Secondary outcomes:
measure: The cumulative incidence of successful weaning by Day 30
timeFrame: from admission to discharge, assessed up to 1 day
measure: Maximum inspiratory pressure
timeFrame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
measure: Diaphragm thickening rate
timeFrame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
measure: Diaphragmatic excursion
timeFrame: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
measure: Length of ICU stay
timeFrame: from admission to discharge, assessed up to 1 day
measure: Cumulative incidence for death before successful weaning
timeFrame: from admission to discharge, assessed up to 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Rehabilitation Hospital of Capital Medical University
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
References: