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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039966
Receipt No. R000044984
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
Date of disclosure of the study information 2020/04/01
Last modified on 2020/11/29

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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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