Acute Respiratory Distress SyndromeNCT02870894
Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients
An observational study of Acute Respiratory Distress Syndrome, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients with ARDS will be enrolled between August 2016 and August 2017 when they fulfilled the inclusion criteria,and unfulfilled the exclusion criteria below
Who may be able to join
- Patients will be included in this study if the following criteria have been met:
- Males and females > 18 years old and <85 years old (non-pregnant, non-lactating females).
- Patients fulfilled the Berlin diagnostic criteria of ARDS
- Signed written informed consent has been obtained
- Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
Who cannot join
- Females who are pregnant or lactating.
- Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)
- Patients <18 years old or > 85 years old
- Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
- Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
hongli He, Ph.D, +86-28-87393633, doctorhhl2016@126.com
Xiaobo Huang, MD
About this study
Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique
Measured: once the patient was consented and enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Hongli, Sichuan Provincial People's Hospital
- Investigators
- Xiaobo Huang, MD, Principal investigator, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870894
- Sponsor's protocol ID
- SichuanPPH
- Status last verified
- Aug 2016
- First submitted
- 14 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao Z, He H, Luo J, Adler A, Zhang X, Liu R, Lan Y, Lu S, Luo X, Lei Y, Frerichs I, Huang X, Moller K. Detection of pulmonary oedema by electrical impedance tomography: validation of previously proposed approaches in a clinical setting. Physiol Meas. 2019 Jun 4;40(5):054008. doi: 10.1088/1361-6579/ab1d90.
PubMed 31035265
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography for Quantification of Pulmonary Edema in Acute Respiratory Distress Syndrome Patients
- ClinicalTrials.gov ID
- NCT02870894
- Acronym / sponsor ID
- SichuanPPH
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- 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.
Evaluation of pulmonary edema is a key factor in monitoring and guidance of therapy in acute respiratory distress syndrome (ARDS) patients. To date, methods available at the bedside for estimating the physiologic correlate of pulmonary edema, extravascular lung water(EVLW), often are unreliable or require invasive measurements. The purpose of the this study is to develop a novel approach to reliably assess extravascular lung water by electrical impedance tomography(EIT).
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients with ARDS will be enrolled between August 2016 and August 2017 when they fulfilled the inclusion criteria,and unfulfilled the exclusion criteria below
Key inclusion criteria (5 listed)
- Males and females > 18 years old and <85 years old (non-pregnant, non-lactating females).
- Patients fulfilled the Berlin diagnostic criteria of ARDS
- Signed written informed consent has been obtained
- Patients had monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
Key exclusion criteria (5 listed)
- Females who are pregnant or lactating.
- Patients with contraindication of EIT(Skin abrasions or wounds in the chest area.Patients with pacemakers or paced EKG rhythms.Thoracic deformity. Severe subcutaneous emphysema)
- Patients <18 years old or > 85 years old
- Patients Without monitoring system Pulse-Induced Contour Cardiac Output (PiCCO)
- Patients with Cardiac function of grade 4 or patients with acute myocardial infarction or acute coronary syndrome
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
Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique
Time frame: once the patient was consented and enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 31035265Zhao Z, He H, Luo J, Adler A, Zhang X, Liu R, Lan Y, Lu S, Luo X, Lei Y, Frerichs I, Huang X, Moller K. Detection of pulmonary oedema by electrical impedance tomography: validation of previously proposed approaches in a clinical setting. Physiol Meas. 2019 Jun 4;40(5):054008. doi: 10.1088/1361-6579/ab1d90.
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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.
Xiaobo Huang, MD principal investigator
Sichuan Academy of Medical Sciences
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 Acute Respiratory Distress Syndrome, run by Sichuan Provincial People's Hospital 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 5 inclusion and 5 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 18 Aug 2016. 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 Hongli He, Ph.D (+86-28-87393633, doctorhhl2016@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between a novel EIT-based method to estimate pulmonary edema (lung water ratio-EIT ) with a conventional measurement for EVLW using trans-cardiopulmonary thermodilution technique (time frame: once the patient was consented and enrolled). 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 NCT02870894, which also lists 1 linked publication.
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 18 Aug 2016.