COPDNCT05585060
The Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients
A study testing the changes of end expiratory lung impedence and the changes of end expiratory lung volume in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The pathophysiological characteristics of respiratory failure on exacerbation of chronic pulmonary obstructive disease are the rapid deteriorate of respiratory symptoms, combined with aggravated flow limitation, gas trapping, dynamic pulmonary hyperinflation (DPH), therefore the intrinsic PEEP (PEEPi) increases. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- the changes of end expiratory lung impedence and the changes of end expiratory lung volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2022to 8 Oct 2023
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2022.7-2023.1 exacerbation COPD invasive ventilated patients admitted to the first affiliated Guangzhou medical university; 35 to 80 years old; in stable condition judged by clinicians
Who cannot join
- SpO2<88%; instable hemodynamic (MAP<65mmHg；Norepinephrine> 0.1ug/kg.min); pregnancy; 4 hour intravenous diuretics use before research; chest deformity and trauma, subpleural pulmonary bulla; implanted electronic devices(cardiac pacemaker, implantable cardioversion defibrillator,ect); tumour or other organ dysfunction; refuse to signature the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical
Guangzhou, Guangdong, 510120
Wei Fu, MD, +8602083062882, hooray_009@163.com
About this study
Official title: The Relevance and Consistency Study of Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients
The pathophysiological characteristics of respiratory failure on exacerbation of chronic pulmonary obstructive disease are the rapid deteriorate of respiratory symptoms, combined with aggravated flow limitation, gas trapping, dynamic pulmonary hyperinflation (DPH), therefore the intrinsic PEEP (PEEPi) increases. It is worthwhile to explore bedside methods to quantify the changes in dynamic pulmonary hyperinflation to guide safe and effective mechanical ventilation in airflow limited patients.
Read the detailed description
The study hypothesizes that the electrical impedence tomography (EIT) measured the changes of end expiratory lung impedence (△EELI） could accurately predict the changes of end expiratory lung volume （△EELV） measured by passive expiratory in controlled mechanical ventilated exacerbation COPD patients. The research intended to conduct a research to explore the relationship between △EELI and △EELV induced by external PEEP changes in ventilated exacerbation COPD patients.
- Conditions
- COPD
- Being tested
- the changes of end expiratory lung impedence, the changes of end expiratory lung volume
- Keywords
- COPD, dynamic pulmonary hyperinflation, mechanical ventilation, end expiratory lung impedence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the changes of end expiratory lung impedenceDiagnostic test
Also called △EELI
the changes of end expiratory lung impedence measured by EIT
the changes of end expiratory lung volumeDiagnostic test
Also called △EELV
the changes of end expiratory lung volume measured by apnea method
| Study group | Role | What they receive |
|---|---|---|
| PEEP titration for mechanical ventilated AECOPD patients | Experimental | Pre- and post-self-controlled trials for invasive mechanical ventilated AECOPD patients during PEEP titration. Receives: Diagnostic Test: the changes of end expiratory lung impedence; Diagnostic Test: the changes of end expiratory lung volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of end expiratory lung volume
measured by EIT and IC maneuver
Measured: 10 minutes
Secondary outcomes (1)
intrinsic PEEP
measured by Esophageal balloon catheters
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start13 Sep 2022
- Primary completion8 Oct 2023 (estimated)
- Study completion8 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FuWei, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, PhD, Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585060
- Sponsor's protocol ID
- FAHGuangzhou_20220711
- Status last verified
- Nov 2022
- First submitted
- 15 Oct 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- 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 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance and Consistency Study of Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients
- ClinicalTrials.gov ID
- NCT05585060
- Acronym / sponsor ID
- FAHGuangzhou_20220711
- Conditions
- COPD
- Keywords
- COPD, dynamic pulmonary hyperinflation, mechanical ventilation, end expiratory lung impedence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 8 Oct 2023 (estimated)
- Study completion
- 8 Oct 2023 (estimated)
- First posted
- 18 Oct 2022 (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.
The pathophysiological characteristics of respiratory failure on exacerbation of chronic pulmonary obstructive disease are the rapid deteriorate of respiratory symptoms, combined with aggravated flow limitation, gas trapping, dynamic pulmonary hyperinflation (DPH), therefore the intrinsic PEEP (PEEPi) increases. It is worthwhile to explore bedside methods to quantify the changes in dynamic pulmonary hyperinflation to guide safe and effective mechanical ventilation in airflow limited patients.
Detailed description
The study hypothesizes that the electrical impedence tomography (EIT) measured the changes of end expiratory lung impedence (△EELI） could accurately predict the changes of end expiratory lung volume （△EELV） measured by passive expiratory in controlled mechanical ventilated exacerbation COPD patients. The research intended to conduct a research to explore the relationship between △EELI and △EELV induced by external PEEP changes in ventilated exacerbation COPD patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEP titration for mechanical ventilated AECOPD patients | Experimental | Diagnostic Test: the changes of end expiratory lung impedence, Diagnostic Test: the changes of end expiratory lung volumePre- and post-self-controlled trials for invasive mechanical ventilated AECOPD patients during PEEP titration. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2022.7-2023.1 exacerbation COPD invasive ventilated patients admitted to the first affiliated Guangzhou medical university; 35 to 80 years old; in stable condition judged by clinicians
Key exclusion criteria (1 listed)
- SpO2<88%; instable hemodynamic (MAP<65mmHg；Norepinephrine> 0.1ug/kg.min); pregnancy; 4 hour intravenous diuretics use before research; chest deformity and trauma, subpleural pulmonary bulla; implanted electronic devices(cardiac pacemaker, implantable cardioversion defibrillator,ect); tumour or other organ dysfunction; refuse to signature the informed consent
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 |
|---|---|---|
| the changes of end expiratory lung impedenceAlso: △EELIthe changes of end expiratory lung impedence measured by EIT | Diagnostic test | PEEP titration for mechanical ventilated AECOPD patients |
| the changes of end expiratory lung volumeAlso: △EELVthe changes of end expiratory lung volume measured by apnea method | Diagnostic test | PEEP titration for mechanical ventilated AECOPD patients |
Primary outcome
the changes of end expiratory lung volume
Time frame: 10 minutes
measured by EIT and IC maneuver
1 secondary outcome
intrinsic PEEP
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- 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.
Rongchang Chen, PhD study chair
The First Affiliated Hospital of Guangzhou 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 the changes of end expiratory lung impedence and the changes of end expiratory lung volume in people with COPD, run by The First Affiliated Hospital of Guangzhou 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Fu, MD (+8602083062882, hooray_009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of end expiratory lung volume (time frame: 10 minutes). 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 22 Nov 2022; AzTrials last refreshed its copy on 30 Oct 2026.