UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042971 |
|---|---|
| Receipt number | R000047823 |
| Scientific Title | The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure |
| Date of disclosure of the study information | 2021/01/11 |
| Last modified on | 2023/03/28 20:56:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Acronym
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Scientific Title
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Scientific Title:Acronym
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Region
| Japan |
Condition
Condition
acute respiratory failure, ARDS
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lung-protective mechanical ventilation with the use of lower tidal volumes is beneficial for patients with ARDS and without ARDS. However, there is little evidence about a specific amount of tidal volume less than 10ml/kg/PBW. Achieving 6ml/kg/PBW of tidal volume without neuromuscular blockade is sometimes interrupted by the patients-ventilator asynchrony (PVA).
PVA is defined as a mismatch between the patient breathing efforts with a ventilator's breath delivery. A higher incidence of PVA is significantly related to ICU mortality. Reverse triggering (RT) is one of the types of PVA, which is defined as the inspiratory effort due to the mandatory breathe by a mechanical ventilator. RT is a notable phenomenon because the incidence of RT is almost fifty percent of mechanically ventilated ARDS patients and RT may exacerbate the lung injury. Lower tidal volume may also relate to the incidence of RT according to a prospective multicenter observational study.
Therefore, this study aims to investigate the incidence of RT in mechanically ventilated patients receiving 6ml/kg/PBW compared to 7.5 ml/kg/PBW.
Basic objectives2
Others
Basic objectives -Others
This study aims to clarify the incidence of RT in mechanically ventilated patients with acute respiratory failure (PaO2/FIO2 < 300mmHg) including ARDS, comparing 6 ml/kg PBW of tidal volume with 7.5 ml/kg PBW.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of reverse triggering [Time frame: during 45 minutes]
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tidal volume 6 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
Interventions/Control_2
Tidal volume 7.5 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age > 20 years old, <85 years old
Acute respiratory failure and ARDS (PaO2/FIO2 < 300mmHg)
Those who can obtain written consent from the substitute for participation in this study
Receiving intubation within 72 hours
Being expected to receive mechanical ventilation at least 72 hours.
Key exclusion criteria
Receiving neuromuscular blockage
brain death
bronchoalveolar fistula
post esophageal cancer surgery
contraindication to Edi catheter insertion (Esophageal varices and perforation)
using ECMO (extracorporeal membrane oxygenation)
mechanical ventilation due to asthma and COPD
hemodynamic instability
pregnant patient
Those who are deemed inappropriate by the principal investigator or research co-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Shime |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5456
nshime@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsutoshi |
| Middle name | |
| Last name | Shimatani |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5456
Homepage URL
tatsutoc@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
Tel
0822571551
iryo-seisaku@office.hiroshima-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
| 2021 | Year | 01 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047823
