ARDSPhase 4NCT01825304
The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
A Phase 4 study testing titrated setting peep in people with ARDS and Intra-abdominal Hypertension, run by Nanjing Medical University at 1 site in Switzerland.
Trial summary
Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ARDS, Intra-abdominal Hypertension
- What is being tested?
- titrated setting peep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Jun 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- intra-abdominal hypertension
- mechanical ventilation
- sedation
Who cannot join
- underlying pulmonary disease
- age older than 60 years and younger than 18 years
- vital signs were not stable
- non voluntary
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ventilator
Bern, Canton of Bern, CH-7402
jiang fang zheng, doctor, (+86)025-8086437, shuhj1987@sina.com
About this study
Official title: the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.
- Conditions
- ARDS, Intra-abdominal Hypertension
- Being tested
- titrated setting peep
- Keywords
- mechanical ventilation, Intra-abdominal hypertension, positive end-expiratory pressure
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titrated setting peepDevice
titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.
| Study group | Role | What they receive |
|---|---|---|
| esophageal pressure ,titrated setting | Active comparator | Not described Receives: Device: titrated setting peep |
| ARDSNet recommendations,peep | Other | Not described Receives: Device: titrated setting peep |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-free days
Comparison of two groups the duration of ventilation-free in 28d,ventilator-free day include weaning from mechanical ventilation more than 24h.
Measured: 28d
Secondary outcomes (1)
mortality
28-Day mortality include patients who giving up treatment due to critical condition
Measured: 28d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Principal investigator, Gang Li, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825304
- Sponsor's protocol ID
- CC110-92
- Status last verified
- Oct 2011
- First submitted
- 2 Apr 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01825304
- Acronym / sponsor ID
- CC110-92
- Conditions
- ARDS, Intra-abdominal Hypertension
- Keywords
- mechanical ventilation, Intra-abdominal hypertension, positive end-expiratory pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Apr 2013 (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.
Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esophageal pressure ,titrated setting | Active comparator | Device: titrated setting peep |
| ARDSNet recommendations,peep | Other | Device: titrated setting peep |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- intra-abdominal hypertension
- mechanical ventilation
- sedation
Key exclusion criteria (4 listed)
- underlying pulmonary disease
- age older than 60 years and younger than 18 years
- vital signs were not stable
- non voluntary
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 |
|---|---|---|
| titrated setting peeptitrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group. | Device | ARDSNet recommendations,peep, esophageal pressure ,titrated setting |
Primary outcome
ventilator-free days
Time frame: 28d
Comparison of two groups the duration of ventilation-free in 28d,ventilator-free day include weaning from mechanical ventilation more than 24h.
1 secondary outcome
mortality
Time frame: 28d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing titrated setting peep in people with ARDS and Intra-abdominal Hypertension, run by Nanjing Medical University at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2013. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 li gang, master (+86-025-80860066, leeg871027@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-free days (time frame: 28d). 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 5 Apr 2013.