UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039459 |
|---|---|
| Receipt number | R000044991 |
| Scientific Title | Accuracy evaluation of Main Stream and Side Stream End-Tidal CO2 Monitoring during Non-Invasive positive pressure Ventilation: A randomized crossover trial |
| Date of disclosure of the study information | 2020/02/28 |
| Last modified on | 2022/03/19 20:09:24 |
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Basic information
Public title
End-tidal carbon dioxide (ETCO2) monitoring during Non-invasive ventilation
Acronym
End-tidal carbon dioxide (ETCO2) monitoring during Non-invasive ventilation
Scientific Title
Accuracy evaluation of Main Stream and Side Stream End-Tidal CO2 Monitoring during Non-Invasive positive pressure Ventilation: A randomized crossover trial
Scientific Title:Acronym
MASCAT-NIV trial
Region
| Japan |
Condition
Condition
The patients who are planed for NPPV to prevent respiratory failure after extubation
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Arterial Partial Pressure of Carbon Dioxide (PaCO2) should be maintained within appropriate range during mechanical ventilation. PaCO2 measurement requires the collection of arterial blood. End-tidal carbon dioxide (ETCO2) and venous partial pressure of carbon dioxide (PvCO2) can be used to estimate PaCO2.
Although ETCO2 is used for monitoring intubated patients, a method for measuring ETCO2 during noninvasive positive pressure ventilation (NPPV) has not been established. Side stream ETCO2 monitor for NPPV patients showed a correlation with PaCO2, but the 95% Limits of agreement (LoA) was large, and there was not enough evidence to use in clinical setting. It is unclear whether the sampling with nasal prong and oral scoop in this study could sample exhalation adequately in a NPPV interface.
NPPV cap-ONE mask set (Nihon Kohden) is a unique interface to collect exhalation with inner cups via mask and measured by main stream monitoring.
The purpose of this study is to evaluate the correlation and agreement between ETCO2 and PaCO2 measured by a main stream monitoring using an NPPV cap ONE mask set and a side stream monitoring using nasal prong and oral scoop, and to compare these methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation and agreement between ETCO2 and PaCO2 measured by a main stream monitoring using an NPPV cap-ONE mask set and a side stream monitoring using nasal prong and oral scoop
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inner cup via mask (main stream) group
measurement of ETCO2 using NPPV cap-ONE mask set(Nihon Kohden), CO2 censor kit; TG-980 (Nihon Kohden)
Interventions/Control_2
Nasal prong and oral scoop (side stream) group
measurement of ETCO2 using Smart CapnoLine H Plus O2 (Oridion medical)
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients undergoing mechanical ventilation, planed for NPPV after extubation, are screened.
The patients who pass Spontaneous Breathing Trial (SBT)
, the difference between ETCO2 and PaCO2 5 mmHg or less during SBT, and an arterial line is placed.
Key exclusion criteria
indication for intubation (GCS 8 or less, inability to protect airway, hemodynamic instability, severe hypoxemia)
agitation, intolerance for NPPV
obstructive pulmonary disease
diagnosed pulmonary embolism, or suspected
severe anemia (Hb < 7.0 g/dL)
not to correct blood gas sample
difficult to include decided by physician
not to get consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sakuraya |
Organization
JA Hiroshima General Hospital
Division name
Department of Emergency and Intensive Care medicine
Zip code
738-8503
Address
Jigozen 1-3-3, Hatsukaichi city, Hiroshima
TEL
+91-829-36-3111
sakuraya-hma@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sakuraya |
Organization
JA Hiroshima General Hospital
Division name
Department of Emergency and Intensive Care medicine
Zip code
738-8503
Address
Jigozen 1-3-3, Hatsukaichi city, Hiroshima
TEL
+81-829-36-3111
Homepage URL
sakuraya-hma@umin.ac.jp
Sponsor or person
Institute
JA Hiroshima General Hospital
Institute
Department
Personal name
Funding Source
Organization
JA Hiroshima General Hospital
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
Ethics Committee, JA Hiroshima General Hospital
Address
Jigozen 1-3-3, Hatsukaichi city, Hiroshima
Tel
+81-829-36-3111
kyukyu@hirobyo.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
JA広島総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-022-00603-w
Number of participants that the trial has enrolled
60
Results
Among patients who underwent NIV to prevent post-extubation respiratory failure, both PETCO2 monitoring methods demonstrated a good correlation with PaCO2. Compared with the measurement during SBT, mean bias using the novel method was similar, whereas it was larger in patients using the previous method. Furthermore, the difference between PaCO2 and PETCO2 in most patients using the novel method was within an acceptable range.
Results date posted
| 2022 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044991
