SepsisNCT03341572
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
A study testing 5,10 and 15cmH2O positive end expiratory pressure in people with Sepsis and ARDS, run by Jingyuan,Xu at 1 site in China.
Trial summary
To observe the effect of PEEP on CVP among patients with different respiratory compliance Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, ARDS, Traumatic Brain Injury
- What is being tested?
- 5,10 and 15cmH2O positive end expiratory pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2017to 30 Dec 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with mechanical ventilation and inserted central venous line
Who cannot join
- The age is less than 18 years old or more than 80 years old；
- Pregnant and lying-in woman；
- Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
- Patients with norepinephrine dose are greater than 15 micro per minute；
- Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
- Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210000
chenglong liang, master, 15261893562, 15261893562@163.com
yi yang, doctor, +8602583262550, yiyiyang2004@163.com
About this study
To observe the effect of PEEP on CVP among patients with different respiratory compliance
Read the detailed description
30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.
- Conditions
- Sepsis, ARDS, Traumatic Brain Injury
- Being tested
- 5,10 and 15cmH2O positive end expiratory pressure
- Medical subject headings
- Sepsis, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5,10 and 15cmH2O positive end expiratory pressureOther
every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points
| Study group | Role | What they receive |
|---|---|---|
| high response group | Experimental | patients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O Receives: Other: 5,10 and 15cmH2O positive end expiratory pressure |
| low response group | Placebo comparator | the change of CVP is less than 2.5cmH2O Receives: Other: 5,10 and 15cmH2O positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVP
Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start13 Nov 2017 (estimated)
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingyuan,Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- yi yang, doctor, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341572
- Sponsor's protocol ID
- 2017ZDSYLL094-P01
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
- ClinicalTrials.gov ID
- NCT03341572
- Acronym / sponsor ID
- 2017ZDSYLL094-P01
- Conditions
- Sepsis, ARDS, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jingyuan,XuUniversity, hospital or other
- Study start
- 13 Nov 2017 (estimated)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 14 Nov 2017 (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 effect of PEEP on CVP among patients with different respiratory compliance
Detailed description
30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high response group | Experimental | Other: 5,10 and 15cmH2O positive end expiratory pressurepatients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O |
| low response group | Placebo comparator | Other: 5,10 and 15cmH2O positive end expiratory pressurethe change of CVP is less than 2.5cmH2O |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with mechanical ventilation and inserted central venous line
Key exclusion criteria (6 listed)
- The age is less than 18 years old or more than 80 years old；
- Pregnant and lying-in woman；
- Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
- Patients with norepinephrine dose are greater than 15 micro per minute；
- Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
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 |
|---|---|---|
| 5,10 and 15cmH2O positive end expiratory pressureevery patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points | Other | high response group, low response group |
Primary outcome
CVP
Time frame: half an hour
Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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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.
yi yang, doctor study chair
Zhongda 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 5,10 and 15cmH2O positive end expiratory pressure in people with Sepsis and ARDS, run by Jingyuan,Xu 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 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. 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. Some participants in this study may receive a placebo. 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 chenglong liang, master (15261893562, 15261893562@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVP (time frame: half an hour). 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 14 Nov 2017.