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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023180
Receipt No. 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

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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
Email 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
Email voice_575@live.jp

Sponsor
Institute Department of Anesthesiology,
The University of Tokyo Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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