UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031833 |
|---|---|
| Receipt number | R000036337 |
| Scientific Title | Assessment of the factors affecting endotracheal tube cuff pressure by continuous measurement during one lung ventilation: A prospective observational study |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2018/03/21 17:12:58 |
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Basic information
Public title
Assessment of the factors affecting endotracheal tube cuff pressure by continuous measurement during one lung ventilation: A prospective observational study
Acronym
Assessment of the factors affecting endotracheal tube cuff pressure by continuous measurement during one lung ventilation: A prospective observational study
Scientific Title
Assessment of the factors affecting endotracheal tube cuff pressure by continuous measurement during one lung ventilation: A prospective observational study
Scientific Title:Acronym
Assessment of the factors affecting endotracheal tube cuff pressure by continuous measurement during one lung ventilation: A prospective observational study
Region
| Japan |
Condition
Condition
lung cancer
pneumothorax
interstitial pneumonia
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the factors elevating double lumen endotrachal tube cuff pressure by continuous measurement during one lung ventilation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tracheal cuff pressure/bronchial cuff pressure
Key secondary outcomes
sore throat
hoarseness
cough
duration of oxygen therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients scheduled to one lung ventilation using a left double lumen endotracheal tube for lung surgery.
Key exclusion criteria
1)pre-existig upper respiratory symptoms such as sore throat/hoarseness/cough
2)severe ventilatory impairment
3)home oxygen therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Irisawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Anesthesiology
Zip code
Address
6-16-1 Tomiokahigashi,Kanazawa-ku,Yokohama
TEL
045-701-9581
tomo.irisawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Irisawa |
Organization
Kanagawa Cardiovascular and Respiratoty Center
Division name
Department of Anesthesiology
Zip code
Address
6-16-1 Tomiokahigashi,Kanazawa-ku,Yokohama
TEL
045-701-9581
Homepage URL
tomo.irisawa@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2018 | Year | 03 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To measure continuously the double lumen tube cuff pressure,we utilize the pressure transducer system via a three-way stopcock connected to each pilot balloons.The high intraoperative cuff pressure is defined as when the pressure exceeds 22mmHg ,over 10 minutes,the factors affecting incidence of the intraoperative high cuff pressure are assessed using logistic regression analysis.
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036337
