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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024101
Receipt No. 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

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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
Email 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
Email suzukima@med.teikyo-u.ac.jp

Sponsor
Institute Department of Otolaryngology,
Teikyo University Chiba Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.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


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