Respiratory FailureNCT04081142
Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients
An observational study of Respiratory Failure and Hypoxemia, run by Yun Long at 1 site in China.
Trial summary
This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypoxemia, ARDS, Human
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Jul 2020
- Phase
- Observational
- 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
Study population: adult patients within 7days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for clinical requirment were eligible for the study.
Who may be able to join
- Time of admission ICU < 7days
- Age (> 18 years old)
- Have been placed central venous catheter based on clinical requirement
Who cannot join
- .Chest skin injured and cannot be monitored by EIT.
- Severe Hypernatremia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100730
About this study
Official title: Application of Indicator Based-EIT Method Assess Lung Regional Perfusion for Critically Ill Patients in ICU
This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU
Read the detailed description
- Written informed consent was obtained from all patients or next of kin before data were included in the study.
- When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study.
- Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL).
- The 10%NaCL was injected by the central venous catheter.
- Conditions
- Respiratory Failure, Hypoxemia, ARDS, Human
- Keywords
- EIT, pulmonary perfusion
- Medical subject headings
- Respiratory Insufficiency, Hypoxia, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute respiratory failure group | acute respiratory failure (ARF) group: arterial oxygen partial pressure to fractional inspired oxygen ratio, PaO2/FiO2<300 mmHg and/or peripheral oxygen saturation SaO2<94% under air condition and/or severe dyspnea with respiratory rate >30bpm. | |
| control group | postoperative ICU patients without ARF were included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung regional perfusion
Lung regional perfusion monitored by EIT with saline
Measured: Hour 1
oxygenation
oxygenation(SpO2) measured by bedside monitor
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 May 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yun Long
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Long, Peking Union Medical College Hospital
- Investigators
- Yun Long, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081142
- Sponsor's protocol ID
- EIT-lung Perfusion in ICU
- Status last verified
- Dec 2020
- First submitted
- 3 Sep 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Q, Su L, Jiang J, Wang N, He H, Long Y. Incorporating electrical impedance tomography to transpulmonary pressure-guided PEEP in severe ARDS with pneumothorax and multiple cavitations: a case report. Front Med (Lausanne). 2023 Aug 28;10:1240321. doi: 10.3389/fmed.2023.1240321. eCollection 2023.
PubMed 37700773He H, Chi Y, Long Y, Yuan S, Zhang R, Yang Y, Frerichs I, Moller K, Fu F, Zhao Z. Three broad classifications of acute respiratory failure etiologies based on regional ventilation and perfusion by electrical impedance tomography: a hypothesis-generating study. Ann Intensive Care. 2021 Aug 28;11(1):134. doi: 10.1186/s13613-021-00921-6.
PubMed 34453622
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Indicator Based-EIT Method Assess Lung Regional Perfusion for Critically Ill Patients in ICU
- ClinicalTrials.gov ID
- NCT04081142
- Acronym / sponsor ID
- EIT-lung Perfusion in ICU
- Conditions
- Respiratory Failure, Hypoxemia, ARDS, Human
- Keywords
- EIT, pulmonary perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Yun LongUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 9 Sep 2019 (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.
This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU
Detailed description
- Written informed consent was obtained from all patients or next of kin before data were included in the study.
- When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study.
- Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL).
- The 10%NaCL was injected by the central venous catheter.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute respiratory failure group | – | –acute respiratory failure (ARF) group: arterial oxygen partial pressure to fractional inspired oxygen ratio, PaO2/FiO2<300 mmHg and/or peripheral oxygen saturation SaO2<94% under air condition and/or severe dyspnea with respiratory rate >30bpm. |
| control group | – | –postoperative ICU patients without ARF were included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients within 7days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for clinical requirment were eligible for the study.
Key inclusion criteria (3 listed)
- Time of admission ICU < 7days
- Age (> 18 years old)
- Have been placed central venous catheter based on clinical requirement
Key exclusion criteria (3 listed)
- .Chest skin injured and cannot be monitored by EIT.
- Severe Hypernatremia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung regional perfusion
Time frame: Hour 1
Lung regional perfusion monitored by EIT with saline
oxygenation
Time frame: Hour 1
oxygenation(SpO2) measured by bedside monitor
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 21 Dec 2020.
- Derived from this study: PubMed 37700773Wang Q, Su L, Jiang J, Wang N, He H, Long Y. Incorporating electrical impedance tomography to transpulmonary pressure-guided PEEP in severe ARDS with pneumothorax and multiple cavitations: a case report. Front Med (Lausanne). 2023 Aug 28;10:1240321. doi: 10.3389/fmed.2023.1240321. eCollection 2023.
- Derived from this study: PubMed 34453622He H, Chi Y, Long Y, Yuan S, Zhang R, Yang Y, Frerichs I, Moller K, Fu F, Zhao Z. Three broad classifications of acute respiratory failure etiologies based on regional ventilation and perfusion by electrical impedance tomography: a hypothesis-generating study. Ann Intensive Care. 2021 Aug 28;11(1):134. doi: 10.1186/s13613-021-00921-6.
- Individual participant dataSharing planned: Undecided
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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.
Yun Long study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Hypoxemia, run by Yun Long 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 3 inclusion and 3 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 21 Dec 2020. 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?
Lung regional perfusion (time frame: Hour 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081142, which also lists 2 linked publications.
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 21 Dec 2020.