ARDSNCT03498807
A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients
A study testing Ventiltor P/V Loop and Electrical Impedance Tomography in people with ARDS and Acute Respiratory Distress Syndrome, run by Hui-Ju Hsu at 1 site in Taiwan.
Trial summary
The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- ARDS, Acute Respiratory Distress Syndrome
- What is being tested?
- Ventiltor P/V Loop and Electrical Impedance Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Apr 2017to 28 Feb 2019
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)
Who cannot join
- On pacemaker
- Pregnant
- Thoracic or spinal cord trauma
- Pneumothorax
- Hemodynamic instability
- IICP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients
The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:
First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.
Read the detailed description
Acute respiratory distress syndrome (ARDS)，over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP，the alveolar pressure is greater than the atmospheric pressure when exhaled，So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.
The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation，there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:
First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.
- Conditions
- ARDS, Acute Respiratory Distress Syndrome
- Being tested
- Ventiltor P/V Loop, Electrical Impedance Tomography
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, PEEP, pressure-volume loop, Positive End-Expiratory Pressure, hysteresis
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventiltor P/V LoopDevice
determine the Optimal PEEP and keep 48hr on ARDS patients
Electrical Impedance TomographyDevice
determine Optimal PEEP and keep 48hr on ARDS patients
| Study group | Role | What they receive |
|---|---|---|
| Control group_Use Ventilator P/V tool | Experimental | Use the Pressure/Volume Loop Receives: Device: Ventiltor P/V Loop |
| Study group_Use EIT | Active comparator | Use the Electrical Impedance Tomography Receives: Device: Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the survival rate between two groups
Calculate the survival rate
Measured: Compare the survival rate between two groups during 91 days in hospitalization
Secondary outcomes (1)
Oxygention improve rate in the hospital
Calculate PaO2/FiO2 ratio improvement rate in the hospital
Measured: Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start13 Apr 2017
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hui-Ju Hsu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui-Ju Hsu, Far Eastern Memorial Hospital
- Investigators
- Hou T Chang, doctor, Study director, Far Eastern Memorial HospitalPing H Wang, Bachelor, Study director, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498807
- Sponsor's protocol ID
- 106094-E
- Status last verified
- Oct 2019
- First submitted
- 5 Apr 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Still in the research phase.May be consider later
Publications
Xu L, Wang Z, Li T, Li Z, Hu X, Feng Q, Duan D, Gao X. [Comparison of extracorporeal membrane oxygenation and mechanical ventilation for inter-hospital transport of severe acute respiratory distress syndrome patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2014 Nov;26(11):789-93. doi: 10.3760/cma.j.issn.2095-4352.2014.11.005. Chinese.
PubMed 25399892Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.
PubMed 23362167Sahetya SK, Brower RG. Lung Recruitment and Titrated PEEP in Moderate to Severe ARDS: Is the Door Closing on the Open Lung? JAMA. 2017 Oct 10;318(14):1327-1329. doi: 10.1001/jama.2017.13695. No abstract available.
PubMed 28973075
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients
- ClinicalTrials.gov ID
- NCT03498807
- Acronym / sponsor ID
- 106094-E
- Conditions
- ARDS, Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, PEEP, pressure-volume loop, Positive End-Expiratory Pressure, hysteresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hui-Ju HsuUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 17 Apr 2018 (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 study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:
First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.
Detailed description
Acute respiratory distress syndrome (ARDS)，over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP，the alveolar pressure is greater than the atmospheric pressure when exhaled，So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.
The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation，there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:
First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)
| Arm | Type | Receives |
|---|---|---|
| Control group_Use Ventilator P/V tool | Experimental | Device: Ventiltor P/V LoopUse the Pressure/Volume Loop |
| Study group_Use EIT | Active comparator | Device: Electrical Impedance TomographyUse the Electrical Impedance Tomography |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)
Key exclusion criteria (6 listed)
- On pacemaker
- Pregnant
- Thoracic or spinal cord trauma
- Pneumothorax
- Hemodynamic instability
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 |
|---|---|---|
| Ventiltor P/V Loopdetermine the Optimal PEEP and keep 48hr on ARDS patients | Device | Control group_Use Ventilator P/V tool |
| Electrical Impedance Tomographydetermine Optimal PEEP and keep 48hr on ARDS patients | Device | Study group_Use EIT |
Primary outcome
Compare the survival rate between two groups
Time frame: Compare the survival rate between two groups during 91 days in hospitalization
Calculate the survival rate
1 secondary outcome
Oxygention improve rate in the hospital
Time frame: Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later
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 22 Oct 2019.
- Results publication: PubMed 25399892Xu L, Wang Z, Li T, Li Z, Hu X, Feng Q, Duan D, Gao X. [Comparison of extracorporeal membrane oxygenation and mechanical ventilation for inter-hospital transport of severe acute respiratory distress syndrome patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2014 Nov;26(11):789-93. doi: 10.3760/cma.j.issn.2095-4352.2014.11.005. Chinese.
- Results publication: PubMed 23362167Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.
- Results publication: PubMed 28973075Sahetya SK, Brower RG. Lung Recruitment and Titrated PEEP in Moderate to Severe ARDS: Is the Door Closing on the Open Lung? JAMA. 2017 Oct 10;318(14):1327-1329. doi: 10.1001/jama.2017.13695. No abstract available.
- Individual participant dataSharing planned: No. Still in the research phase.May be consider later
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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.
Hou T Chang, doctor study director
Far Eastern Memorial Hospital
Ping H Wang, Bachelor study director
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventiltor P/V Loop and Electrical Impedance Tomography in people with ARDS and Acute Respiratory Distress Syndrome, run by Hui-Ju Hsu at 1 site in Taiwan.
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 6 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 22 Oct 2019. 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 Taiwan. 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?
Compare the survival rate between two groups (time frame: Compare the survival rate between two groups during 91 days in hospitalization). 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 NCT03498807, which also lists 3 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 22 Oct 2019.