UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044712 |
|---|---|
| Receipt number | R000051066 |
| Scientific Title | Accuracy of non-invasive cardiac output measurement in awake patients |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/06/04 11:20:06 |
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Basic information
Public title
Accuracy of non-invasive cardiac output measurement in awake patients
Acronym
Accuracy of non-invasive cardiac output measurement in awake patients
Scientific Title
Accuracy of non-invasive cardiac output measurement in awake patients
Scientific Title:Acronym
Accuracy of non-invasive cardiac output measurement in awake patients
Region
| Japan |
Condition
Condition
Postoperative patients transferred to the intensive care unit under intubation
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the accuracy of non-invasive cardiac output measurement (esCCO) and cardiac output measurements by pulmonary artery catheter in sedation or awake patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of cardiac output measurements during sedation and awake in the same patient
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients over 20 years old undergoing elective cardiovascular surgery with cardiopulmonary bypass
2. Patients planed to place a pulmonary artery catheter for perioperative management
3. Patients scheduled to be transferred to the intensive care unit with intubation for postoperative management
Key exclusion criteria
1. Emergency surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kimitoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Ethics Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2973
ethics@med.nagoya-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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00540-023-03176-6
Number of participants that the trial has enrolled
40
Results
The paired esCCO and TDCO measurements were compared. The respective bias (standard deviation) values were 0.13(0.60) L/min before extubation, and -0.48(0.78) L/min after extubation. The percentage errors were 25.1% before extubation and 29.6% after extubation. Thus, the accuracy of the noninvasive esCCO measurement is clinically acceptable as an alternative to TDCO measurement under different respiratory conditions of mechanical ventilation and spontaneous respiration.
Results date posted
| 2023 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 11 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
The clinical accuracy of the esCCO in various clinical settings. Therefore, we compared the esCCO with TDCO from mechanical ventilation to spontaneous respiration through extubation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051066
