ARDS, HumanNCT03845556
Clinical Study of Titrating PEEP of Different Methods on Right Heart Function
An observational study of ARDS, Human, run by Southeast University, China at 1 site in China.
Trial summary
To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Human
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2018to 30 Mar 2019
- How long will I take part?
- 1 Day
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population admitted to ICU of Zhongda hospital，diagnosed of medium or serious ARDS。
Who may be able to join
- Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria)
- Patients age between 18 years old and 80 years
Who cannot join
- Patients with chronic respiratory diseases such as COPD.
- Ventilated because of oesophageal surgery in the previous 12months.
- Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion.
- Oesophageal bleeding in previous 30 days history of oesophageal varices.
- Facial trauma and surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Feng Mei Guo, Dr, 13813841261, 13813841261@139.com
FengMei Guo, Dr
About this study
Official title: Clinical Study of Titrating PEEP of Different Methods on Right Heart Function and Pulmonary Artery Pressure in ARDS Patients
To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .
Read the detailed description
30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .
- Conditions
- ARDS, Human
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
the function of right heart and pulmonary artery pressure
Systolic Pulmonary Artery Pressure TAPSE or Tricuspid Annular Motion orTricuspid annular plane systolic excursion or right ventricular diameter or right left ventricular diameter ratio in diffrient PEEP
Measured: 2018.4-2019.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start4 Aug 2018
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
- Investigators
- Chun Pan, Dr, Principal investigator, southeast university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845556
- Sponsor's protocol ID
- ARDS
- Status last verified
- Feb 2019
- First submitted
- 11 Oct 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Titrating PEEP of Different Methods on Right Heart Function and Pulmonary Artery Pressure in ARDS Patients
- ClinicalTrials.gov ID
- NCT03845556
- Acronym / sponsor ID
- ARDS
- Conditions
- ARDS, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Zhongda Hospital
- Study start
- 4 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 19 Feb 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.
To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .
Detailed description
30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population admitted to ICU of Zhongda hospital，diagnosed of medium or serious ARDS。
Key inclusion criteria (2 listed)
- Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria)
- Patients age between 18 years old and 80 years
Key exclusion criteria (5 listed)
- Patients with chronic respiratory diseases such as COPD.
- Ventilated because of oesophageal surgery in the previous 12months.
- Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion.
- Oesophageal bleeding in previous 30 days history of oesophageal varices.
- Facial trauma and surgery.
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
the function of right heart and pulmonary artery pressure
Time frame: 2018.4-2019.3
Systolic Pulmonary Artery Pressure TAPSE or Tricuspid Annular Motion orTricuspid annular plane systolic excursion or right ventricular diameter or right left ventricular diameter ratio in diffrient PEEP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
Chun Pan, Dr principal investigator
southeast university
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 ARDS, Human, run by Southeast University, China 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 2 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 19 Feb 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 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 Dutong Yue, Dr (15051887681, 1475008526@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the function of right heart and pulmonary artery pressure (time frame: 2018.4-2019.3). 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 19 Feb 2019.