UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031833
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tomo.irisawa@gmail.com

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.