UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024150 |
|---|---|
| Receipt number | R000027784 |
| Scientific Title | Does endoscopic sinus surgery under general anesthesia increase obstructive sleep apnea syndrome-related respiratory complications during early post-operative period in patients with suspected SAS? |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/09/26 16:02:28 |
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Basic information
Public title
Does endoscopic sinus surgery under general anesthesia increase obstructive sleep apnea syndrome-related respiratory complications during early post-operative period in patients with suspected SAS?
Acronym
ESS under general anesthesia and early post-operative SAS-related respiratory complications
Scientific Title
Does endoscopic sinus surgery under general anesthesia increase obstructive sleep apnea syndrome-related respiratory complications during early post-operative period in patients with suspected SAS?
Scientific Title:Acronym
ESS under general anesthesia and early post-operative SAS-related respiratory complications
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea Syndrome (OSAS)
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An observational study aimed to assess the incidence of sleep apnea syndrome (SAS)-related early post-operative respiratory events (number of apnea events, oxygen desaturation index changes) in patients with suspected obstructive SAS (OSAS) undergoing endoscopic sinus surgery under general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in number of apnea events per hour and oxygen desaturation index values during post-operative days 0-3 (POD0-3)
Key secondary outcomes
1) Pre-oprative detection of OSAS in patients with suspected OSAS and planned ESS; severity of pre-operatively diagnosed OSAS
2) Effectiveness of ESS on OSAS-related symptoms in patients with pre-operatively suspected SAS
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Not-diagnosed and not-treated OSAS patients with suspected OSAS in whom ESS is planned
2) Three or more points on modified STOP-BANG scale before surgery
Key exclusion criteria
1) Not obtained consent for the study
2) Two or less points on modified STOP-BANG scale before surgery
3) Patients with diagnosed OSAS
4) Patients receiving treatment for OSAS (CPAP etc.)
5) Patients with American Society of Anesthesiologists' Physical Status of III or more
6) Patients with severe respiratory or circulatory disease
7) Patients participating in other clinical research (clinical trial or other studies) during last 3 month period
8) Patients not considered eligible for the present study by members of the research team
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomasz |
| Middle name | |
| Last name | Hascilowicz |
Organization
The Jikei University School of Medicine, Dai-San Hospital
Division name
Department of Anesthesiology
Zip code
201-8601
Address
4-11-1 Izumi-honcho, Komae-shi, Tokyo 201-0003
TEL
03-3480-1151
hascilowicz@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Tomasz |
| Middle name | |
| Last name | Hascilowicz |
Organization
The Jikei University School of Medicine, Dai-San Hospital
Division name
Department of Anesthesiology
Zip code
201-8601
Address
4-11-1 Izumi-honcho, Komae-shi, Tokyo 201-0003
TEL
03-3480-1151
Homepage URL
hascilowicz@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Department of Anesthesiology
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
The Jikei University Institutional Review Board
Address
3-19-18 Nishi-Shinbashi, Minatok-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
| 2016 | Year | 10 | Month | 01 | 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
25
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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 09 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027784
