Critical IllnessNCT04951960
The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony
A study testing Higher PEEP setting and Lower PEEP setting in people with Critical Illness, run by Osaka University at 1 site in Japan.
Trial summary
Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Higher PEEP setting and Lower PEEP setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2020to 31 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≧ 18 years old
- Patients with moderate to severe ARDS under mechanical ventilation＊ ＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)
Who cannot join
- Lack of informed consent
- Continuous neuromuscular blockade at enrollment
- DNR (do-not-resuscitate)
- Moribund patient not expected to survive 24 hours
- Massive hemoptysis
- Increased intracranial pressure (> 18 mmHg)
Show all 10Show fewer
- Existence or high risk of pneumothorax
- Known pregnancy
- Actual body weight exceeding 1 kg/cm
- Patient judged to be inappropriate for the trial by intensivist
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Osaka University Hospital
Suita, Osaka
Takeshi Yoshida, M.D., Ph.D., +81668795820, takeshiyoshida@hp-icu.med.osaka-u.ac.jp
About this study
Official title: The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony in Patients With Acute Respiratory Distress Syndrome: a Cross-Over Randomized Trial
Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.
Read the detailed description
The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.
- Conditions
- Critical Illness
- Being tested
- Higher PEEP setting, Lower PEEP setting
- Keywords
- patient ventilator asynchrony, positive end expiratory pressure
- Medical subject headings
- Critical Illness, Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher PEEP settingOther
PEEP levels are determined according to the higher PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.
Lower PEEP settingOther
PEEP levels are determined according to the lower PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| A group from higher PEEP to lower PEEP | Other | Patient allocated for this arm are received from higher to lower PEEP setting. Receives: Other: Higher PEEP setting; Other: Lower PEEP setting |
| A group from lower PEEP to higher PEEP | Other | Patient allocated for this arm are received from lower to higher PEEP setting. Receives: Other: Higher PEEP setting; Other: Lower PEEP setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.
Measured: Through study completion (up to 24 hours)
Secondary outcomes (4)
Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.
Measured: Through study completion (up to 24 hours)
The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP
Measured: Through study completion (up to 24 hours)
Minute volume at higher and lower PEEP
Measured: Through study completion (up to 24 hours)
The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.
Measured: Through study completion (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Nov 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Takeshi Yoshida, M.D., Ph.D., Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951960
- Sponsor's protocol ID
- PEEPPVA
- Status last verified
- Nov 2020
- First submitted
- 1 Nov 2020
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Higher Positive End Expiratory Pressure on Patient-Ventilator Asynchrony in Patients With Acute Respiratory Distress Syndrome: a Cross-Over Randomized Trial
- ClinicalTrials.gov ID
- NCT04951960
- Acronym / sponsor ID
- PEEPPVA
- Conditions
- Critical Illness
- Keywords
- patient ventilator asynchrony, positive end expiratory pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 7 Jul 2021 (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.
Patient-ventilator asynchrony is known to frequently occur during lung protective ventilation in patients with ARDS. Previous clinical studies showed that patient-ventilator asynchrony was associated with worse outcome in ICU. Therefore, strategies to reduce patient-ventilator asynchrony need to be established promptly. Several asynchronies, e.g., breath stacking are caused by vigorous spontaneous breathing effort. Recently, the investigators' group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, the investigators conjectured that higher PEEP may reduce the intensity of spontaneous breathing effort and thereby reduce patient-ventilator asynchrony during protective ventilation strategy, compared with lower PEEP in patients with ARDS.
Detailed description
The cross-over study will enroll 10 participants fulfilled with the criteria of Berlin definition of moderate-to-severe ARDS and under mechanical ventilation in intensive care unit (ICU) at Osaka University Hospital. Informed consent will be obtained by legal representatives. After obtaining informed consent, participants will be randomly assigned to one of two groups: "higher PEEP - lower PEEP" or "lower PEEP - higher PEEP". PEEP, either higher or lower, will be set according to higher or lower PEEP/FIO2 table. The depth of sedation will be monitored quantitively and maintained to be the same throughout the protocol. The intensity of spontaneous breathing activity will be assessed with esophageal balloon manometry and electrical activity of diaphragm. At each PEEP setting, asynchrony index will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group from higher PEEP to lower PEEP | Other | Other: Higher PEEP setting, Other: Lower PEEP settingPatient allocated for this arm are received from higher to lower PEEP setting. |
| A group from lower PEEP to higher PEEP | Other | Other: Higher PEEP setting, Other: Lower PEEP settingPatient allocated for this arm are received from lower to higher PEEP setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≧ 18 years old
- Patients with moderate to severe ARDS under mechanical ventilation＊ ＊ Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 200 mmHg with PEEP ≧ 5 cmH2O)
Key exclusion criteria (10 listed)
- Lack of informed consent
- Continuous neuromuscular blockade at enrollment
- DNR (do-not-resuscitate)
- Moribund patient not expected to survive 24 hours
- Massive hemoptysis
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 |
|---|---|---|
| Higher PEEP settingPEEP levels are determined according to the higher PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour. | Other | A group from higher PEEP to lower PEEP, A group from lower PEEP to higher PEEP |
| Lower PEEP settingPEEP levels are determined according to the lower PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour. | Other | A group from higher PEEP to lower PEEP, A group from lower PEEP to higher PEEP |
Primary outcome
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.
Time frame: Through study completion (up to 24 hours)
4 secondary outcomes
Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.
Time frame: Through study completion (up to 24 hours)
The intensity of spontaneous breathing effort measured by esophageal manometry at higher and lower PEEP
Time frame: Through study completion (up to 24 hours)
Minute volume at higher and lower PEEP
Time frame: Through study completion (up to 24 hours)
The efficiency of diaphragmatic contraction measured by electrical activity of diaphragm at higher and lower PEEP.
Time frame: Through study completion (up to 24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
Takeshi Yoshida, M.D., Ph.D. principal investigator
Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher PEEP setting and Lower PEEP setting in people with Critical Illness, run by Osaka University at 1 site in Japan.
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 10 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 15 Jul 2021. 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 Japan. 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 Takeshi Yoshida, M.D., Ph.D. (+81668795820, takeshiyoshida@hp-icu.med.osaka-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP. (time frame: Through study completion (up to 24 hours)). 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 15 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.