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CompletedNCT06642701Updated Nov 5, 2024

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

An interventional study of Electrical Impedance Tomography and chest physiotherapy in Community Acquired Pneumonia, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Apr 2022, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Community Acquired Pneumonia

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 84 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    EIT-guided group

    Physical therapy guided by EIT

    Device: Electrical Impedance Tomography · Behavioral: chest physiotherapy

  • Other
    Non-EIT-guided group

    Traditional physical therapy

    Behavioral: chest physiotherapy

Interventions

  • DeviceElectrical Impedance Tomography

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

  • Behavioralchest physiotherapy

    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.

06

What researchers measure

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\&#39;s clinical condition is and the more timely treatment is needed. When the CPIS score is ≤6, the discontinuation of antibiotics can be considered.

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

Other outcomes

  1. Length of stay

    The length of stay for each patient.

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

  2. Short Form 36

    The Short Form-36 (SF-36) scale was used to assess quality of life. The lowest score represents the worst health status. SF-36 measurement was performed twice, before and after treatment.

    Time frame: At baseline and at week 2.

  3. Satisfaction with treatment

    Using the Australian respiratory rehabilitation package, divided into 5 items, each item 5 points, a total of 25. The original questionnaire contained six items on which patients rated their satisfaction with respiratory rehabilitation on a scale of 1 strongly disagree to 5 strongly agree.

    Time frame: Evaluation was conducted 12 hours before discharge.

  4. Regional Ventilation distribution

    Difference in regional ventilation distribution before and after institution of physical therapy

    Time frame: From baseline measurements to immediately after the end of treatment (15 minutes)

07

Study locations

1 site
  • Jingyi Ge
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06642701
Lead sponsor
Capital Medical University
Responsible party
Jingyi Ge (Principal Investigator, Capital Medical University) — Principal investigator
First posted
Oct 15, 2024
Start date
Apr 1, 2022
Primary completion
Mar 30, 2024
Completion
Mar 30, 2024
Last update
Nov 5, 2024

Study contacts

Jingyi Ge
principal investigator · Beijing Rehabilitation Hospital of Capital Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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