UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044567 |
|---|---|
| Receipt number | R000050910 |
| Scientific Title | Tolerability of prone positioning in non-intubated patients with hypoxemia due to COVID-19-related pneumonia |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2022/06/18 19:24:04 |
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Basic information
Public title
Tolerability of prone positioning in non-intubated patients with hypoxemia due to COVID-19-related pneumonia
Acronym
Tolerability of prone positioning in non-intubated patients with hypoxemia due to COVID-19-related pneumonia
Scientific Title
Tolerability of prone positioning in non-intubated patients with hypoxemia due to COVID-19-related pneumonia
Scientific Title:Acronym
Tolerability of prone positioning in non-intubated patients with hypoxemia due to COVID-19-related pneumonia
Region
| Japan |
Condition
Condition
COVID-19-related pneumonia
Classification by specialty
| Pneumology | Infectious disease | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tolerability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and physician assessment of whether to continue prone positioning at 5 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The patient was asked to turn to the prone position at least 3 hours per day intermittently or continuously, and 5 days continuously.
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) they were aged over 20 years
2) they were diagnosed with COVID-19-related pneumonia with a consistent capillary oxygen saturation (SpO2) <=93% requiring supplement oxygen therapy and not requiring intubation immediately
3) they were given written informed consent.
Key exclusion criteria
1) they had hemodynamic instability; sustained systolic blood pressure < 90 mmHg, sustained mean blood pressure < 65 mmHg or requirement for vasopressor),
2) they were pregnant or lactating
3) they had been received surgery or trauma of face, thorax, abdomen or pelvis
4) they had pneumothorax.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiichoro |
| Middle name | |
| Last name | Sakao |
Organization
Graduate School of Medicine, Chiba University, Chiba, Japan
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
81432222576
sakaos@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Shikano |
Organization
Graduate School of Medicine, Chiba University, Chiba, Japan
Division name
Department of Respirology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
81432222576
Homepage URL
kshikano@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Chiba University Hospital Clinical Research Center
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
81432262734
prc-jim@chiba-u.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 | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | 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 | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050910
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/06/18 | 資料6-1 試験計画書 ver.2.3.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/06/18 | SAP_ver1.0_20210921.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/06/18 | Data sharing.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/50910
