Mechanical Ventilation ComplicationPEEPNCT04081155
Effect of PEEP on Lung Regional Ventilation and Perfusion
An observational study of Mechanical Ventilation Complication and Respiratory Failure, run by Yun Long at 1 site in China.
Trial summary
Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Respiratory Failure, Hypoxia
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jun 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 7 days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study
Who may be able to join
- have been placed central venous catheter based on patient's condition
- Under mechanically ventilation
- Under sedation and control ventilation mode
- Year>18
Who cannot join
- Pneumothorax
- pregnancy
- Severe chest wall wound
- Severe hypernatremia
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality
About this study
Official title: Effect of Positive End-expiratory Pressure(PEEP) on Regional Ventilation and Perfusion Estimated by Indicator-based Electrical Impedance Tomography(EIT) Method in Critically Ill Patients With Mechanical Ventilation
Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT
Read the detailed description
- When the research team was available, adult patients within 7days who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study.
- Written informed consent was obtained from all patients or next of kin before data were included in the study.
- Information collected at enrollment included demographic characteristics, such as age, sex.
- The blood pressure（BP）,heart rate（HR）, pulse O2（SpO2）,tidal volume and lung regional ventilation and perfusion were collected at PEEP 0 centimeter H2O column and PEEP 12-15 centimeter H2O column.
- Indicator-based EIT method: rapidly inject 10ml 10% Sodium chloride（NaCL） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by EIT machine
- Keywords
- EIT, pulmonary perfusion, ventilation
- Medical subject headings
- Respiratory Insufficiency, Hypoxia, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
lung regional ventilation distribution
lung regional ventilation distribution measured by EIT
Measured: Hour 1
lung regional perfusion distribution
lung regional perfusion distribution measured by EIT
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 Jan 2019
- Primary completion28 May 2020
- Study completion1 Jun 2020
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 Mechanical Ventilation ComplicationStudies 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
- 33 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
- NCT04081155
- Sponsor's protocol ID
- PEEP-lung perfusion
- Acronym
- PEEP
- Status last verified
- Jan 2019
- First submitted
- 3 Sep 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He H, Chi Y, Long Y, Yuan S, Frerichs I, Moller K, Fu F, Zhao Z. Influence of overdistension/recruitment induced by high positive end-expiratory pressure on ventilation-perfusion matching assessed by electrical impedance tomography with saline bolus. Crit Care. 2020 Sep 29;24(1):586. doi: 10.1186/s13054-020-03301-x.
PubMed 32993811
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-expiratory Pressure(PEEP) on Regional Ventilation and Perfusion Estimated by Indicator-based Electrical Impedance Tomography(EIT) Method in Critically Ill Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04081155
- Acronym / sponsor ID
- PEEP / PEEP-lung perfusion
- Keywords
- EIT, pulmonary perfusion, ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yun LongUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 1 Jun 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.
Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT
Detailed description
- When the research team was available, adult patients within 7days who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study.
- Written informed consent was obtained from all patients or next of kin before data were included in the study.
- Information collected at enrollment included demographic characteristics, such as age, sex.
- The blood pressure（BP）,heart rate（HR）, pulse O2（SpO2）,tidal volume and lung regional ventilation and perfusion were collected at PEEP 0 centimeter H2O column and PEEP 12-15 centimeter H2O column.
- Indicator-based EIT method: rapidly inject 10ml 10% Sodium chloride（NaCL） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by EIT machine
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients within 7 days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study
Key inclusion criteria (4 listed)
- have been placed central venous catheter based on patient's condition
- Under mechanically ventilation
- Under sedation and control ventilation mode
- Year>18
Key exclusion criteria (4 listed)
- Pneumothorax
- pregnancy
- Severe chest wall wound
- Severe hypernatremia
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 ventilation distribution
Time frame: Hour 1
lung regional ventilation distribution measured by EIT
lung regional perfusion distribution
Time frame: Hour 1
lung regional perfusion distribution measured by EIT
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 14 Jul 2020.
- Derived from this study: PubMed 32993811He H, Chi Y, Long Y, Yuan S, Frerichs I, Moller K, Fu F, Zhao Z. Influence of overdistension/recruitment induced by high positive end-expiratory pressure on ventilation-perfusion matching assessed by electrical impedance tomography with saline bolus. Crit Care. 2020 Sep 29;24(1):586. doi: 10.1186/s13054-020-03301-x.
- 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 Mechanical Ventilation Complication and Respiratory Failure, 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 4 inclusion and 4 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 14 Jul 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 ventilation distribution (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 NCT04081155, 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 14 Jul 2020.