UMIN-CTR Clinical Trial

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
Email	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
Email	hascilowicz@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine Department of Anesthesiology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027784

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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