Clinical trial NCT06642701: Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia
Official title: Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 84
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: In this study, electrical impedance tomography (EIT), a noninvasive and nonradiative technology, is applied to guide the accurate respiratory rehabilitation of pneumonia. On the basis of traditional physical assessment, physiotherapists introduce EIT as an auxiliary imaging technology into the field of rehabilitation, which can increase the accurate understanding of ventilation conditions of local lung lesions, so as to optimize physical therapy methods, which is conducive to the improvement of patients' symptoms, the improvement of lesions, and the improvement of patients' quality of life.

Detailed description: According to the results of traditional assessment, physiotherapists and clinicians discussed the EIT results to give respiratory rehabilitation chest physiotherapy, and adjusted the treatment according to the results of T2 and T3 review. EIT has dynamic monitoring charts and communicates with patients about the changes after treatment.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Meet the diagnostic criteria of CAP：(1) community onset; (2) pneumonia-related clinical manifestations: recent onset of cough, expectoration or worsening of symptoms of preexisting respiratory diseases, with or without sputum purulence, chest pain, dyspnea or hemoptysis; Fever; Signs of lung consolidation and/or moist rales were heard; Peripheral white blood cell count \> 10×109/L or \< 4×109/L, with or without nuclear shift to the left. (3) Chest imaging examination: new patchy infiltrates, lobar/segmental consolidation, ground glass opacity or interstitial changes, with or without pleural effusion. The clinical diagnosis was established when any one of (1), (3) or (2) was met, excluding pulmonary tuberculosis, lung tumor, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil infiltration and pulmonary vasculitis.
* Meet the diagnostic criteria of HAP： Referring to the Chinese adult (2018 edition), it refers to the new-onset pneumonia within 48 hours after admission of patients who have not received invasive mechanical ventilation during hospitalization and are not in the incubation period of pathogenic infection. "That is, new or progressive infiltrates appear in the lung, and there are more than two of the following symptoms: fever, increased neutrophils (\>10×109/L) or decreased neutrophils (\<5×109/L), purulent sputum.
* The need for chest physical therapy for patients with pneumonia was determined jointly by the rehabilitation treatment team including clinicians, rehabilitation physicians and therapists, and the consent of patients and their families was obtained.

Exclusion Criteria

* Invasive or noninvasive mechanical ventilation；
* Ventilator-associated pneumonia；
* permanent or temporary cardiac pacemaker installed in the body；
* Moderate or massive pleural effusion；
* Severe pneumonia: disturbance of consciousness; Respiratory rate ≥ 30 breaths /min; PaO2\<60 mmHg, PaO2/FiO2\<300, need mechanical ventilation treatment; Systolic arterial pressure \<90 mmHg; Complicated with septic shock; Chest X-ray showed bilateral or multi-lobar involvement or lesion enlargement ≥ 50% within 48 hours after admission；Urine output\<20 mL/h, or \<80 mL/4 h, or complicated with acute renal failure requiring dialysis treatment；Patients with one or more of these parameters were diagnosed as severe disease；
* body mass index\> 30kg/m2；
* Lung cancer；
* Acute exacerbation of chronic obstructive pulmonary disease and acute exacerbation of bronchial asthma；
* Viral pneumonia.

Primary outcomes:
measure: Clinical pulmonary infection score
timeFrame: Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.
Secondary outcomes:
Other outcomes:
measure: Length of stay
timeFrame: From admission to discharge, assessed up to 1 day
measure: Short Form 36
timeFrame: At baseline and at week 2.
measure: Satisfaction with treatment
timeFrame: Evaluation was conducted 12 hours before discharge.
measure: Regional Ventilation distribution
timeFrame: From baseline measurements to immediately after the end of treatment (15 minutes)
Locations:
city: Beijing
country: China
facility: Jingyi Ge
Study officials:
affiliation: Beijing Rehabilitation Hospital of Capital Medical University
name: Jingyi Ge
role: PRINCIPAL_INVESTIGATOR
References: