UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050093 |
|---|---|
| Receipt number | R000057065 |
| Scientific Title | Comparison of end-tidal carbon dioxide and brain tissue oxygen saturation as predictors of return of spontaneous circulation in out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2025/01/23 09:16:33 |
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Basic information
Public title
Comparison of end-tidal carbon dioxide and brain tissue oxygen saturation as predictors of return of spontaneous circulation in out-of-hospital cardiac arrest
Acronym
Predicting resuscitation rate in patients with cardiac arrest using end-tidal carbon dioxide and brain tissue oxygen saturation
Scientific Title
Comparison of end-tidal carbon dioxide and brain tissue oxygen saturation as predictors of return of spontaneous circulation in out-of-hospital cardiac arrest
Scientific Title:Acronym
Predicting resuscitation rate in patients with cardiac arrest using end-tidal carbon dioxide and brain tissue oxygen saturation
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between brain tissue oxygen saturation and end-tidal carbon dioxide values alone and in combination with return of spontaneous circulation in out-of-hospital cardiac arrest patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of return of spontaneous circulation (ROSC)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Out-of-hospital cardiac arrest (OHCA)
Key exclusion criteria
Patient unable to wear a probe due to skin damage to the forehead area
Patients who have requested to be excluded through opt-out
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
tkawaguchi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawaguchi |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
tkawaguchi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Takeshi Kawaguchi
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyogakubu, Daigakuin Kenkyu Suishinka
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2023 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
55
Results
Among 55 patients, 13 achieved ROSC. The ROSC group exhibited higher initial_StO2 and initial_ETCO2 levels, with delta_StO2 (final_StO2-initial_StO2) being greater, unlike delta_ETCO2. ROSC frequency was higher in patients with initial_StO2>35% and delta_StO2>5%. Discriminant analysis with paired data of initial_ETCO2 and delta_StO2 showed clear discrimination.
Results date posted
| 2024 | Year | 07 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
delay of writing the manuscript
Date of the first journal publication of results
Baseline Characteristics
Among the 359 OHCA patients, 304 (84.7%) were excluded because of age (n=4) and no NIRS assessment (n=300). Ultimately, 55 patients were enrolled and both ETCO2 and StO2 were measured. Among them, 13 (23.6%) achieved ROSC.
Participant flow
Upon emergency department admission, ETCO2 and StO2 were assessed using an ETCO2 capnometer (TG-980, NIHON KOHDEN, Shinjuku, Tokyo, Japan) and NIRS (tNIRS-1, Hamamatsu Photonics, Hamamatsu, Shizuoka, Japan). We used tNIRS-1 for non-invasive and continuous measurement of absolute StO2 values, allowing direct quantitative analysis. ETCO2 probes were attached during intubation, whereas the tNIRS-1 probe was placed on the patient's forehead upon arrival by the emergency medical technicians.
Adverse events
none
Outcome measures
ETCO2 and StO2 were evaluated at the initiation (initial_ETCO2/initial_StO2) and termination of the measurement (final_ETCO2/final_StO2). Termination occurred when patients achieved ROSC or resuscitation was terminated. Differences in ETCO2/StO2 between the initial and final values were delta_ETCO2 and delta_StO2, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
On arrival of the out-of-hospital cardiac arrest patient, the NIRS monitor and ETCO2 sensor are attached. This measures initial values and changes in brain tissue oxygen saturation and end-tidal carbon dioxide partial pressure.
Management information
Registered date
| 2023 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057065
