Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia

NCT06642701 | Completed DMC

• 1 other identifier: 2022-2-2252
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical pulmonary infection score

  CPIS is a comprehensive assessment of the severity of infection based on clinical, radiological, and microbiological criteria, including body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progression of pulmonary infiltrates, and tracheal aspirate culture. The maximum score was 12 and the minimum score is 0 points.. It is of great significance in the diagnosis, treatment and evaluation of pneumonia, and has high application value.The higher the CPIS score, the more serious the patient\'s clinical condition is and the more timely treatment is needed. When the CPIS score is ≤6, the discontinuation of antibiotics can be considered.

  Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.

Other Outcomes (4)

• Length of stay

  From admission to discharge, assessed up to 1 day

• Short Form 36

  At baseline and at week 2.

• Satisfaction with treatment

  Evaluation was conducted 12 hours before discharge.

Study Arms (2)

EIT-guided group

EXPERIMENTAL

Physical therapy guided by EIT

Device: Electrical Impedance Tomography; Behavioral: chest physiotherapy

Non-EIT-guided group

OTHER

Traditional physical therapy

Behavioral: chest physiotherapy

Interventions

Electrical Impedance Tomography DEVICE

According to the results of traditional assessment, physiotherapists and clinicians discussed the EIT results to give respiratory rehabilitation chest physiotherapy

EIT-guided group

chest physiotherapy BEHAVIORAL

Conventional assessment by physical therapists was followed by respiratory rehabilitation chest physiotherapy.Chest physical therapy for respiratory rehabilitation includes postural drainage, cough technique, forced expiratory technique, positive expiratory pressure, high-frequency chest wall compression, chest tapping, vibration, active breathing cycle technique, etc. All chest physiotherapy was performed by 1 therapist.

EIT-guided group; Non-EIT-guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Jingyi Ge

Beijing, China

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Jingyi Ge

  Beijing Rehabilitation Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: October 15, 2024
• Study Start: April 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)