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

November 4, 2024 updated by: Jingyi Ge, Capital Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Jingyi Ge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EIT-guided group
Physical therapy guided by EIT
Device: Electrical Impedance Tomography
According to the results of traditional assessment, physiotherapists and clinicians discussed the EIT results to give respiratory rehabilitation chest physiotherapy
Behavioral: chest 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.
Other: Non-EIT-guided group
Traditional physical therapy
Behavioral: chest 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before respiratory rehabilitation chest physiotherapy (T1), on days 3 (T2) and 7 (T3) after the start of treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From admission to discharge, assessed up to 1 day
The length of stay for each patient.
From admission to discharge, assessed up to 1 day
Short Form 36
Time Frame: At baseline and at week 2.
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.
At baseline and at week 2.
Satisfaction with treatment
Time Frame: Evaluation was conducted 12 hours before discharge.
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.
Evaluation was conducted 12 hours before discharge.
Regional Ventilation distribution
Time Frame: From baseline measurements to immediately after the end of treatment (15 minutes)
Difference in regional ventilation distribution before and after institution of physical therapy
From baseline measurements to immediately after the end of treatment (15 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jingyi Ge, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-2-2252

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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