ARDS, HumanNCT05442073
Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS
An observational study of ARDS, Human and PEEP, Occult, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS, Human, PEEP, Occult, Esophageal and Pleural Pressure
- What is being tested?
- PEEP adjustment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 29 Jun 2022
- How long will I take part?
- 28 Days
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients all the moderate to severe ARDS with P/F<200 no contraindication to esophageal catheter
Who may be able to join
- aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation
Who cannot join
- aged<18 contraindication to esophageal catheter
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Effect of Initial Empirical Positive End-Expiratory Pressure (PEEP) Setting on the Esophageal Pressure-guided PEEP Titration in Acute Respiratory Distress Syndrome
Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type II（ΔPes<30%ΔPEEP）.
- Conditions
- ARDS, Human, PEEP, Occult, Esophageal and Pleural Pressure
- Being tested
- PEEP adjustment
- Medical subject headings
- Respiratory Distress Syndrome, Positive-Pressure Respiration, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP adjustmentOther
adjusting PEEP about 3-5cmH2O (increase or decrease)
| Study group | Role | What they receive |
|---|---|---|
| Type I: ΔPes≥30%ΔPEEP | Not described Receives: Other: PEEP adjustment | |
| Type II: ΔPes<30%ΔPEEP | Not described Receives: Other: PEEP adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of esophageal pressure during the PEEP titration
Measured: March 1st to May 31st, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Mar 2022
- Primary completion31 May 2022
- Study completion29 Jun 2022
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.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuyang Zhang, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442073
- Sponsor's protocol ID
- ZS-2458
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Initial Empirical Positive End-Expiratory Pressure (PEEP) Setting on the Esophageal Pressure-guided PEEP Titration in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05442073
- Acronym / sponsor ID
- ZS-2458
- Conditions
- ARDS, Human, PEEP, Occult, Esophageal and Pleural Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 1 Jul 2022 (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.
Esophageal manometry was used as surrogate of pleural pressure to titrate positive end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients, the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type II（ΔPes<30%ΔPEEP）.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type I: ΔPes≥30%ΔPEEP | – | Other: PEEP adjustment |
| Type II: ΔPes<30%ΔPEEP | – | Other: PEEP adjustment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients all the moderate to severe ARDS with P/F<200 no contraindication to esophageal catheter
Key inclusion criteria (1 listed)
- aged over 18 all the moderate to severe ARDS patients invasive mechanical ventilation
Key exclusion criteria (1 listed)
- aged<18 contraindication to esophageal catheter
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 |
|---|---|---|
| PEEP adjustmentadjusting PEEP about 3-5cmH2O (increase or decrease) | Other | Type I: ΔPes≥30%ΔPEEP, Type II: ΔPes<30%ΔPEEP |
Primary outcome
the changes of esophageal pressure during the PEEP titration
Time frame: March 1st to May 31st, 2022
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 1 Jul 2022.
- 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.
Shuyang Zhang, MD 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 ARDS, Human and PEEP, Occult, run by Peking Union Medical College Hospital 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 1 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 1 Jul 2022. 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?
the changes of esophageal pressure during the PEEP titration (time frame: March 1st to May 31st, 2022). 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 1 Jul 2022.