UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028999 |
|---|---|
| Receipt number | R000033181 |
| Scientific Title | Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery. |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2017/09/05 09:57:28 |
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Basic information
Public title
Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Acronym
Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Scientific Title
Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Scientific Title:Acronym
Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic or open abdominal surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By monitoring the cuff pressure during laparoscopic and open abdominal surgery continuously , in order to investigate the effect of the cuff pressure by pneumoperitoneum.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cuff pressure from the start of pneumoperitoneum and start of the surgery to 15 minutes
Key secondary outcomes
Presence or absence of pharyngalgia, dysphagia, hoarseness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The cuff pressure measurement using the cuff pressure gauge
Interventions/Control_2
The cuff pressure measurement using the cuff pressure gauge
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
| 21 | years-old | <= |
Age-upper limit
| 87 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who obtained the consent
Key exclusion criteria
Patients who did not obtain the consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tennichi |
Organization
Kanazawa University Hospital
Division name
Department of anesthesia
Zip code
Address
13-1 Takaramachi, Kanazawa-shi, Ishikawa-ken
TEL
076-265-2434
impulse1225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tennichi |
Organization
Kanazawa University Hospital
Division name
Department of anesthesia
Zip code
Address
13-1 Takaramachi, Kanazawa-shi, Ishikawa-ken
TEL
076-265-2434
Homepage URL
impulse1225@yahoo.co.jp
Sponsor or person
Institute
Komatsu Municipal Hospital
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
| 2017 | Year | 09 | Month | 05 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 07 | Month | 02 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033181
