UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039453 |
|---|---|
| Receipt number | R000044976 |
| Scientific Title | The Study on the Silent Regurgitation During Spine Surgery |
| Date of disclosure of the study information | 2020/02/12 |
| Last modified on | 2020/02/11 08:22:35 |
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Basic information
Public title
The Study on the Silent Regurgitation During Spine Surgery
Acronym
The Study on the Silent Regurgitation During Spine Surgery
Scientific Title
The Study on the Silent Regurgitation During Spine Surgery
Scientific Title:Acronym
The Study on the Silent Regurgitation During Spine Surgery
Region
| Japan |
Condition
Condition
spine diseases
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the frequency of gastroesophageal reflux during surgery in the prone position
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The investigation of the frequency of gastroesophageal reflux during spine surgery
Key secondary outcomes
To clarify the risk factors of gastroesophageal reflux during spine surgery
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective spine surgery.
Written informed consent will be obtained from all subjects.
Key exclusion criteria
Emergency surgery
ASA physical status >= 4
Patients with kidney disease
Patients taking PPI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Miyazaki |
Organization
Kenai Kinen Hospital
Division name
Department of Anesthesiology
Zip code
8114313
Address
1191, Oazakimori, Ongagun Ongacho, Fukuoka
TEL
+81932937090
miyary1208@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Miyazaki |
Organization
Kenai Kinen Hospital
Division name
Department of Anesthesiology
Zip code
8114313
Address
1191, Oazakimori, Ongagun Ongacho, Fukuoka
TEL
+81932937090
Homepage URL
miyary1208@yahoo.co.jp
Sponsor or person
Institute
Kenai Kinen Hospital
Institute
Department
Personal name
Funding Source
Organization
Kenai Kinen Hospital
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
Kenai Kinen Hospital IRB
Address
1191, Oazakimori, Ongagun Ongacho, Fukuoka
Tel
+81932937090
kenaikinenhospital@bell.ocn.ne.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
健愛記念病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1)Written informed consent is obtained from all study subjects
(2)Following clinical information is obtained from medical record: age, gender, height, weight, medical history, ECG, blood pressure, heart rate, blood test, anesthesia record
(3)Collect oral secretions several times (after induction, after prone position, every hour after start of surgery) and record changes in oral pH using pH test paper.
Management information
Registered date
| 2020 | Year | 02 | Month | 11 | Day |
Last modified on
| 2020 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044976
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
