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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039453
Receipt No. 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

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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
Email 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
Email miyary1208@yahoo.co.jp

Sponsor
Institute Kenai Kinen Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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