Community Acquired PneumoniaNCT06642701
Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia
A study testing Electrical Impedance Tomography and chest physiotherapy in people with Community Acquired Pneumonia, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Electrical Impedance Tomography and chest physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- Lung cancer；
- Acute exacerbation of chronic obstructive pulmonary disease and acute exacerbation of bronchial asthma；
- Viral pneumonia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia: a Randomized Controlled Study
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.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Electrical Impedance Tomography, chest physiotherapy
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance TomographyDevice
According to the results of traditional assessment, physiotherapists and clinicians discussed the EIT results to give respiratory rehabilitation chest physiotherapy
chest physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided group | Experimental | Physical therapy guided by EIT Receives: Device: Electrical Impedance Tomography; Behavioral: chest physiotherapy |
| Non-EIT-guided group | Other | Traditional physical therapy Receives: Behavioral: chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Apr 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Jingyi Ge, Principal investigator, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642701
- Sponsor's protocol ID
- 2022-2-2252
- Status last verified
- Nov 2024
- First submitted
- 20 Aug 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Imaging Techniques in Guiding the Use of Chest Physiotherapy in Patients with Pneumonia: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06642701
- Acronym / sponsor ID
- 2022-2-2252
- Conditions
- Community Acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-guided group | Experimental | Device: Electrical Impedance Tomography, Behavioral: chest physiotherapyPhysical therapy guided by EIT |
| Non-EIT-guided group | Other | Behavioral: chest physiotherapyTraditional physical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Impedance TomographyAccording to the results of traditional assessment, physiotherapists and clinicians discussed the EIT results to give respiratory rehabilitation chest physiotherapy | Device | EIT-guided group |
| chest physiotherapyConventional 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. | Behavioural | EIT-guided group, Non-EIT-guided group |
Primary outcome
Clinical pulmonary infection score
Time frame: Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyi Ge principal investigator
Beijing Rehabilitation Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Impedance Tomography and chest physiotherapy in people with Community Acquired Pneumonia, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pulmonary infection score (time frame: Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.