UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024101 |
|---|---|
| Receipt number | R000027746 |
| Scientific Title | Noninvasive perioperative measurement of intrathoracic pressure using pulse wave sensor in patients who underwent nasal surgeries. |
| Date of disclosure of the study information | 2016/09/19 |
| Last modified on | 2017/09/20 20:58:20 |
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Basic information
Public title
Noninvasive perioperative measurement of intrathoracic pressure using pulse wave sensor in patients who
underwent nasal surgeries.
Acronym
Noninvasive perioperative intrathoracic pressure measurement with pulse wave sensor.
Scientific Title
Noninvasive perioperative measurement of intrathoracic pressure using pulse wave sensor in patients who
underwent nasal surgeries.
Scientific Title:Acronym
Noninvasive perioperative intrathoracic pressure measurement with pulse wave sensor.
Region
| Japan |
Condition
Condition
Nasal allergy, chronic sinusitis,
nasal deviation
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of perioperative safety in patients who underwent bilateral nasal surgeries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurements of intrathoracic pressure and SpO2 preoperatively, on the 1st, and the 6th postoperative day.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic sinusitis, nasal allergy, or septum deviation who underwent bilateral endoscopic nasal and sinus surgeries under general anesthesia.
Key exclusion criteria
Patients who underwent unilateral endoscopic nasal and sinus surgeries
Patients who underwent endoscopic nasal and sinus surgeries under local anesthesia
Patients whom did not underwent bilateral insertion of nasal packing
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Suzuki |
Organization
Teikyo University Chiba Medical Center
Division name
Otolaryngology
Zip code
Address
3426-3, Anesaki, Ichihara, Chiba, Japan
TEL
0436621211
suzukima@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Suzuki |
Organization
Teikyo University Chiba Medical Center
Division name
Otolaryngology
Zip code
Address
3426-3, Anesaki, Ichihara, Chiba, Japan
TEL
0436621211
Homepage URL
suzukima@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology,
Teikyo University Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Otolaryngology,
Teikyo University Chiba Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study: measurements of intrathoracic pressure and SpO2 preoperatively, on the 1st, and the 6th postoperative day.
Management information
Registered date
| 2016 | Year | 09 | Month | 19 | Day |
Last modified on
| 2017 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027746
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/09/20 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/09/20 | 研究症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/09/20 | 研究症例データ.docx |
