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 |
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
The impact of reverse triggering on achieving low tidal volume for patients with respiratory failure
Japan |
acute respiratory failure, ARDS
Intensive care medicine |
Others
NO
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.
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.
Prevalence of reverse triggering [Time frame: during 45 minutes]
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Dose comparison
2
Treatment
Other |
Tidal volume 6 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
Tidal volume 7.5 ml/kg (Predicted Body Weight) [Time frame: during 15 minutes]
20 | years-old | <= |
85 | years-old | > |
Male and Female
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.
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
30
1st name | Nobuaki |
Middle name | |
Last name | Shime |
Hiroshima University
Department of Emergency and Critical Care Medicine
734-8551
1-2-3 Kasumi, Minami-ku, Hiroshima
082-257-5456
nshime@hiroshima-u.ac.jp
1st name | Tatsutoshi |
Middle name | |
Last name | Shimatani |
Hiroshima University
Department of Emergency and Critical Care Medicine
734-8551
1-2-3 Kasumi, Minami-ku, Hiroshima
082-257-5456
tatsutoc@gmail.com
Hiroshima University
Hiroshima University
Other
Ethical Committee for Clinical Research of Hiroshima University
Kasumi 1-2-3 Minami-ku, Hiroshima 734-8551
0822571551
iryo-seisaku@office.hiroshima-u.ac.jp
NO
2021 | Year | 01 | Month | 11 | Day |
Unpublished
Terminated
2020 | Year | 09 | Month | 29 | Day |
2020 | Year | 12 | Month | 23 | Day |
2021 | Year | 01 | Month | 11 | Day |
2024 | Year | 03 | Month | 31 | Day |
2021 | Year | 01 | Month | 11 | Day |
2023 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047823
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |