UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023180 |
|---|---|
| Receipt number | R000026670 |
| Scientific Title | A prospective, observational study to compare pre- with intra-anesthetic airway resistance in patients scheduled for surgery under general anesthesia, using the information on flow-volume curves obtained prior to and during general anesthesia. |
| Date of disclosure of the study information | 2016/07/17 |
| Last modified on | 2019/01/16 09:19:20 |
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Basic information
Public title
A prospective, observational study to compare pre- with intra-anesthetic airway resistance in patients scheduled for surgery under general anesthesia, using the information on flow-volume curves obtained prior to and during general anesthesia.
Acronym
A prospective, observational study to compare pre- with intra-anesthetic airway resistance in patients scheduled for surgery under general anesthesia, using the information on flow-volume curves obtained prior to and during general anesthesia.
Scientific Title
A prospective, observational study to compare pre- with intra-anesthetic airway resistance in patients scheduled for surgery under general anesthesia, using the information on flow-volume curves obtained prior to and during general anesthesia.
Scientific Title:Acronym
A prospective, observational study to compare pre- with intra-anesthetic airway resistance in patients scheduled for surgery under general anesthesia, using the information on flow-volume curves obtained prior to and during general anesthesia.
Region
| Japan |
Condition
Condition
Not applicable
(This is a prospective, observational study involving patients scheduled for surgery under general anesthesia.)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the original presence of airflow limitation is associated with pre- and intra-anesthetic airway resistance in patients who are scheduled to undergo surgery under general anesthesia.
Basic objectives2
Others
Basic objectives -Others
To test the hypothesis that airway resistance under forced expiration approximates to that under mechanical ventilation in patients without airflow limitation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre- and intra-anesthetic airway resistance calculated based on the slopes of flow-volume curves obtained prior to and during general anesthesia.
Static lung compliance calculated as the ratio between VT and plateau pressure minus PEEP.
Key secondary outcomes
Endotracheal tube resistance measured based on the relationship between pressure drop and flow within a certain range of flow rates.
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
| 15 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for open or laparoscopic abdominal, open or laparoscopic gynecological, neurosurgical, orthopedic, ontological, ophthalmic, plastic and dental operation under general anesthesia, all of whose airways are managed by orotracheal intubation with the use of a normal or spiral endotracheal tube.
Key exclusion criteria
Patients scheduled for cardiac and respiratory surgery.
Patients undergoing general anesthesia using a double lumen endotracheal tube, a RAE endotracheal tube and a supraglottic airway devise.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Yamada |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-3815-5411
YAMADAY-ANE@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamistu Ikeda |
Organization
The University of Tokyo Hospital
Division name
Department of Anesthesiology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
+81-3-3815-5411
Homepage URL
http://www.anes.umin.ne.jp/research.html
voice_575@live.jp
Sponsor or person
Institute
Department of Anesthesiology,
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology,
The University of Tokyo Hospital
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 | 07 | Month | 17 | 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 | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this prospective, observational study, we included patients scheduled for surgery under general anesthesia between April 5 and May 31, 2016, all of whom met the selection criteria.
Management information
Registered date
| 2016 | Year | 07 | Month | 15 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026670
