UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042319 |
|---|---|
| Receipt number | R000048290 |
| Scientific Title | The Impact of Higher Positive End Expiratory Pressure on Patient Ventilator Asynchrony |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2021/07/13 19:47:24 |
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Basic information
Public title
The Impact of Higher Positive End Expiratory Pressure on Patient Ventilator Asynchrony
Acronym
The Impact of Higher Positive End Expiratory Pressure on Patient Ventilator Asynchrony
Scientific Title
The Impact of Higher Positive End Expiratory Pressure on Patient Ventilator Asynchrony
Scientific Title:Acronym
The Impact of Higher Positive End Expiratory Pressure on Patient Ventilator Asynchrony
Region
| Japan |
Condition
Condition
Acute Respiratory Distress Syndrome
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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, our group found that higher positive end expiratory pressure (PEEP) reduced the intensity of spontaneous breathing effort of breathing in severe ARDS model (rabbits, pigs) and patients with ARDS. Thus, we 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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asynchrony index of all types of patient ventilator asynchrony at higher and lower PEEP.
Key secondary outcomes
1. Asynchrony index of each types of patient ventilator asynchrony at higher and lower PEEP.
2. The intensity of spontaneous breathing effort at higher and lower PEEP
3. Minute volume at higher and lower PEEP.
4. The efficiency of diaphragmatic contraction at higher and lower PEEP.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Higher positive end expiratory pressure (PEEP)
Interventions/Control_2
Lower positive end expiratory pressure (PEEP)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients over/and 18 years old
2) Patients with moderate-to-severe ARDS under mechanical ventilation
Definition of moderate to severe ARDS is as per the Berlin definition (PaO2/FiO2 under/and 200 mmHg with PEEP over/and 5 cmH2O)
Key exclusion criteria
1) Lack of informed consent
2) Continuous neuromuscular blockade at enrollment
3) DNR (do-not-resuscitate)
4) Moribund patient not expected to survive 24 hours
5) Massive hemoptysis
6) Increased intracranial pressure (> 18 mmHg)
7) Existence or high risk of pneumothorax
8) Known pregnancy
9) Actual body weight exceeding 1 kg/cm
10) Patient judged to be inappropriate for the trial by intensivist
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3133
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3133
Homepage URL
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Osaka University Hospital, Osaka University Hospital
Address
2-2, Yamadaoka, Suita city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048290
