UMIN-CTR Clinical Trial

Basic information
Public title	The effect of nasal passage occlusion with gauze on efficiency of face mask ventilatoin in aessthetised patient requring nasal intubation: a prospective randomised crossover study
Acronym	The effect of nasal passage occlusion with gauze on efficiency of face mask ventilatoin in aessthetised patient
Scientific Title	The effect of nasal passage occlusion with gauze on efficiency of face mask ventilatoin in aessthetised patient requring nasal intubation: a prospective randomised crossover study
Scientific Title:Acronym	The effect of nasal passage occlusion with gauze on efficiency of face mask ventilatoin in aessthetised patient
Region	Japan

Condition
Condition	Mask ventilation in anesthetised patient
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of nasal passage occlusion by gauze on the efficiency of mask ventilaton in anesthetised muscular flaccidity patient who require nasal intubation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Expiratory tidal volume in mechanical mask ventilation with or without nasal passage occlusion by gauze
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Anesthesiolosists perform one minutes mechanical mask ventilation under each condition. Group A: without nasal passage occlusion, followed by occlusion by gauze, followed by removal of gauze, followed by re-occlusion and, finally, insertin nasal airway.
Interventions/Control_2	Anesthesiolosists perform one minutes mechanical mask ventilation under each condition. Group B: nasal passage occlusion by gauze, followed by removal of gauze, followed by re-occlusion, followed by removal of gauze and, finally, inserting nasal airway.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients undergoing elective surgery under general anesthesia requring nasal intubation 2. ASA physical status cllasification: ASA-PS 1/2
Key exclusion criteria	1. possible difficult mask ventilation (Body mass index> 30 kg/m2, thyromental distance< 6 cm, Mallampati score 1 or 2, thickness of neck, having beard, instability or a limitation in range of motion of cervical vertebra, neck mass or past history of radiation therapy in neck, sleep apnea syndrome) 2. risk of aspiration (pregnant, obesity, hiatal hernia, gastroesophageal reflux disease) 3. nasal discharge becouse of upper respiratory infection or hayfever. 4. ischemic heart disease or chronic obstractive pulmonary disease
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Takekoshi
Organization	nagano municipal hospital
Division name	Medical department, division of anesthesia
Zip code	381-8551
Address	1333-1, Ooaza Tomitake, Nagano City, Nagano Prefecture, Japan
TEL	0262951199
Email	anzu804@gmail.com

Public contact
Name of contact person	1st name Masaki Middle name Last name Takekoshi
Organization	nagano municipal hospital
Division name	Medical department, division of anesthesia
Zip code	381-8551
Address	1333-1, Ooaza Tomitake, Nagano City, Nagano Prefecture, Japan
TEL	0262951199
Homepage URL
Email	anzu804@gmail.com

Sponsor
Institute	nagano municipal hospital
Institute
Department

Funding Source
Organization	nagano municipal hospital
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	nagano municipal hospital
Address	1333-1, Ooaza Tomitake, Nagano City, Nagano Prefecture, Japan
Tel	026-295-1199
Email	anzu804@gmail.com

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	地方独立行政法人　長野市民病院（長野県）

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	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 03 Month 25 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 27 Day
Last modified on	2020 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044984

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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