UMIN-CTR Clinical Trial

Basic information
Public title	Assessments of clinical usefulness of a cuff-leak test for safe tracheal extubation: comparison before and after surgery
Acronym	clinical usefulness of cuff leak pressure
Scientific Title	Assessments of clinical usefulness of a cuff-leak test for safe tracheal extubation: comparison before and after surgery
Scientific Title:Acronym	clinical usefulness of cuff leak pressure
Region	Japan

Condition
Condition	Patients undergoing upper abdominal surgery and cervical spine surgery
Classification by specialty	Hepato-biliary-pancreatic surgery Oto-rhino-laryngology Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test an hypothesis that cuff-leak pressure(CLP) increases after surgery (primary hypothesis) and reflects postoperative laryngeal edema assessed by endoscopic observation.
Basic objectives2	Others
Basic objectives -Others	To explore possible techniques assessing postoperative laryngeal edema.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cuff-leak pressure
Key secondary outcomes	vocal cord angle, cuff-leak volume, laryngeal edema score, upper airway ultrasound parameters, neck circumference, tissue elastance, tissue water contents, and so on

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Measurements of cuff leak pressure before and after surgery
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 undergo general anesthesia for upper abdominal surgery or cervical spine surgery
Key exclusion criteria	1) Airway malformation 2) Severe respiratory disease: asthma,pneumonia 3) Severe cardiovascular disease: myocardial infarction 4) Intracranial lesion 5) During dialysis 6) Palatine tonsil hypertrophy(>Grade 3) 7) Severe nasal congestion 8) After head and neck surgery 9) After tracheostomy 10) Difficult intubation, Not applicable for extubation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shiroh Middle name Last name Isono
Organization	Chiba University
Division name	Graduate School of Medicine, Anesthesiology
Zip code	260-8677
Address	1-8-1 Inohana Chuo Chiba
TEL	0432227171
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Yamada
Organization	Chiba University
Division name	Graduate School of Medicine, Anesthesiology
Zip code	260-8677
Address	1-8-1 Inohana Chuo Chiba
TEL	0432227171
Homepage URL
Email	tyamada.vn@gmail.com

Sponsor
Institute	Chiba University
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	Graduate school of medicine school of medicine, Chiba university
Address	1-8-1 Inohana Chuo Chiba
Tel	0432227171
Email	igaku-rinri@office.chiba-u.jp

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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 01 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	2019 Year 12 Month 16 Day
Date of IRB	2020 Year 03 Month 16 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 23 Day
Last modified on	2022 Year 03 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045503