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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000024150 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Obstructive Sleep Apnea Syndrome (OSAS) | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |