UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039966
Receipt number 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 13:11:42

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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 or person

Institute

nagano municipal hospital

Institute

Department

Personal name



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

Value
https://center6.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