UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Yoshitsugu Yamada
Organization	The University of Tokyo Hospital
Division name	Department of Anesthesiology
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	Takamistu Ikeda
Organization	The University of Tokyo Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026670